Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include but are not limited to the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; additional surgical intervention: air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; sterile inflammation or granulomas at the access site;  infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; residual thrombus; tissue necrosis, transient or long lasting; vasospasm; and vessel perforation or dissection. Complications due to X-ray radiation exposure include alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia. The risk of these complications increases as the length and number of procedures increases.

Warnings

• Do not advance or retract catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The system should only be used by physicians trained in interventional neuro-endovascular techniques.
• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents including alcohol and antiseptic solutions. Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the precautions in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions

• Administration of anticoagulants and antiplatelets, medical management, and acute post stroke care should follow the hospital guidelines. Any neurological deterioration should be evaluated by urgent CT scan and other evaluations as indicated according to hospital best practice.
• The FreeClimb aspiration catheter was evaluated for compatibility with agents that include contrast media and heparinized saline. The use of these catheters for delivery of solutions other than the types that have been tested for compatibility has not been evaluated
• Use caution when manipulating, advancing and/or withdrawing the device through stents or other devices with sharp edges or through tortuous or calcified blood vessels as this may damage the coating which may lead to coating material remaining in the vasculature or device damage and require additional intervention.
• Avoid excessive wiping of the device along with wiping with dry gauze as this may damage the device coating.
• Do not soak the device for longer than instructed as this may impact coating performance.
• Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
• Ensure target vessel diameter is appropriate and can accommodate catheter. The vessel diameter should be larger than the catheter outer diameter.
FreeClimb 70 aspiration catheter: vessel ≥ 2.2 mm
FreeClimb 54 aspiration catheter: vessel ≥ 1.7 mm
• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect each device to ensure there is no damage.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry. 
• Torquing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant, pressurized, heparinized saline infusion on all devices.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).
• When aspirating, aspirate for the minimum time required to remove thrombus.
• Monitor intra-procedural blood loss and manage as appropriate.
• In between aspiration passes, withdraw the FreeClimb catheter from the patient and clean any residual thrombus prior to reinsertion and subsequent contrast injection.

Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include but are not limited to the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vasospasm; and vessel perforation or dissection.

Warnings

• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents.
• Do not advance or retract catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The system should only be used by physicians trained in interventional neuro-endovascular techniques.
• Shaped microcatheters may need to be straightened with a guidewire prior to introduction in the Support Catheter.
• Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the precautions in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions

• Use device in vessels that are larger than the outer diameter of the device (≥2.7mm).
• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect device to ensure it is not damaged.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry.
• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated device.
• Avoid using antiseptic solution or other solvents to pre-treat the device because this may cause unpredictable changes in the coating, which could affect device safety and performance.
• Torqueing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant infusion of appropriate flush solution.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).

Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; additional surgical intervention: air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; sterile inflammation or granulomas at the access site; infection; intracranial hemorrhage; ischemia; brain edema; hemorrhagic transformation; kidney damage from contrast media; neurological deficits including stroke; residual thrombus; tissue necrosis, transient or long lasting: vasospasm; and vessel perforation or dissection. Complication due to X-ray radiation exposure include alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia. The risk of these complications increases as the length and number of procedures increases.

Warnings

• Do not advance or retract the catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The system should only be used by physicians trained in interventional neuro-endovascular techniques.
• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents.
• Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the precautions in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
• The safety and effectiveness of mechanical neurothrombectomy devices has only been evaluated via transfemoral access.
• Compatibility with stent retrievers has not been verified.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using Route 92 Medical HiPoint Reperfusion System.

Precautions

• Administration of anticoagulants and antiplatelets, medical management, and acute post stroke care should follow the hospital guidelines. Any neurological deterioration should be evaluated by urgent CT scan and other evaluations as indicated according to hospital best practice.
The Aspiration Catheter was evaluated for compatibility with agents that include contrast media and heparinized saline. The use of these catheters for delivery of solutions other than the types that have been tested for compatibility is not recommended.
• Use caution when manipulating, advancing and/or withdrawing the device through stents or other devices with sharp edges or through tortuous or calcified blood vessels as this may damage the coating which may lead to coating material remaining in the vasculature or device damage and require additional intervention.
• Avoid excessive wiping of the device along with wiping with dry gauze as this may damage the device coating.
• Do not soak the device for longer than instructed as this may impact coating performance.
• Limit the exposure to X-ray radiation doses to patients and physician by using sufficient shielding, reducing fluoroscopy times and modifying X-ray technical factors when possible.
• Ensure target vessel diameter is appropriate and can accommodate catheter. Do not use the Aspiration Catheter in vessels that are smaller than the outer diameter of the catheter (088 Aspiration Catheter outer diameter 2.6 mm; 070 Aspiration Catheter outer diameter 2.1 mm)
• The Route 92 Medical HiPoint Reperfusion Systems are not recommended for use at vacuum pressures beyond 27.5 inHg.
• Store in a cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect each device to ensure there is no damage.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry.
• Torquing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant, pressurized, heparinized saline infusion on all devices.
• If an intraluminal device becomes lodged in the catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and Base Camp Sheath).
• When aspirating, aspirate for the minimum time required to remove thrombus.
• Monitor intra-procedural blood loss and manage as appropriate.
• In between aspiration passes, withdraw the Aspiration Catheter(s) from the patient and clean any residual thrombus prior to reinsertion and subsequent contrast injection.

Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include but are not limited to the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vasospasm; and vessel perforation or dissection.

Warnings

• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents.
• Do not advance or retract catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The system should only be used by physicians trained in interventional neuro-endovascular techniques.
• Shaped microcatheters may need to be straightened with a guidewire prior to introduction in the Support Catheter.
• Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the precautions in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions

• Use device in vessels that are larger than the outer diameter of the device (≥2.7mm).
• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect device to ensure it is not damaged.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry.
• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated device.
• Avoid using antiseptic solution or other solvents to pre-treat the device because this may cause unpredictable changes in the coating, which could affect device safety and performance.
• Torqueing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant infusion of appropriate flush solution.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).
• To avoid damaging the catheter tip, do not steam shape the catheter tip more than twice.

Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include but are not limited to the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; sterile inflammation or granulomas at the access site; additional surgical intervention; tissue necrosis (transient or long-lasting); infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; thrombosis; vasospasm; and vessel perforation or dissection.

Warnings

• Do not advance or retract catheters against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The catheters should only be used by physicians trained in interventional neuro-endovascular techniques.
• Testing has been limited to contrast media and saline. The use of this catheter for delivery of other solutions is not recommended.
• Do not use device in vessels that are smaller than the outer diameter of the device or within tortuous vasculature.
• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents.
• The Sheath System is coated with a hydrophilic coating at the distal end of each device for a length of 8 cm for the Sheath, 15 cm for the Dilator and 40 cm for the Select Catheter. Please refer to the Directions for Use section for further information on how to prepare and use the system to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
• Use caution when manipulating, advancing and/or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events, resulting in coating material remaining in the vasculature or device damage. This may result in adverse events requiring additional intervention.

Precautions

• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect device to ensure it is not damaged.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate each catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry.
• Torquing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant infusion of appropriate flush solution.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).
• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated device
• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
• Avoid pre-soaking the devices as this may impact the coating performance.

Complications

Procedures requiring percutaneous catheter introduction should only be performed by physicians familiar with possible complications. Possible complications include but are not limited to the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; thrombosis; vasospasm; and vessel perforation or dissection.

Warnings

• Do not advance or retract catheters against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
• Do not use a device that has been damaged in any way. Use of a damaged device may result in complications.
• The catheters should only be used by physicians trained in interventional neuro-endovascular techniques.
• Testing has been limited to contrast media and saline. The use of this catheter for delivery of other solutions is not recommended.
• Do not use device in vessels that are smaller than the outer diameter of the device or within tortuous vasculature.
• Do not use high-powered contrast injection equipment. Use could result in damage to the device or vessel.
• Do not reuse or resterilize. The device is intended for single use only. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use opened or damaged packages.
• Do not expose device to solvents.
• The Sheath System is coated with a hydrophilic coating at the distal end of each device for a length of 8 cm for the Sheath, 15 cm for the Dilator and 40 cm for the Select Catheter. Please refer to the Directions for Use section for further information on how to prepare and use the system to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions

• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect device to ensure it is not damaged.
• Use device with fluoroscopic visualization and proper anti-coagulation agents.
• Hydrate each catheter with heparinized saline before use. Once hydrated, do not allow the catheter to dry.
• Torqueing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
• Maintain a constant infusion of appropriate flush solution.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).
• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated device
• Avoid using antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
• Avoid pre-soaking the devices as this may impact the coating performance.