Route 92 Reperfusion and Access Systems combined Safety and Risk Information
See IFU packaged with Route 92 product for complete instructions for use
Indications for Use
The Route 92 Medical FreeClimb® 70 and FreeClimb® 54 Reperfusion Systems
are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The Route 92 Medical FreeClimb® 88 Access System
is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
The Route 92 Medical HiPoint ® 088 and 070 Access Systems
are indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
The Route 92 Medical Base Camp® Sheath System
is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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; 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 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.
• Please refer to the Directions for Use section of the Instructions for Use provided with the product for further information on how to prepare and use the device to ensure it performs as intended. Failure to abide by the instructions in the labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
• Testing has been limited to contrast media and saline. The use of a 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.
• Use caution when manipulating, advancing and/or withdrawing 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
• 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.
• Store in cool, dry, dark place.
• Use prior to the “Use By” date.
• Upon removal from package, inspect each device to ensure 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.
• 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 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.
• If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system.
• Use only a steam source to shape the Delivery Catheter tip.
• After steam shaping, inspect the catheter tip for damage. Do not use a catheter that has been damaged.
• To avoid damaging the catheter tip, do not steam shape the catheter tip more than twice.
For aspiration systems only
• 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 from the patient and clean any residual thrombus prior to reinsertion and subsequent contrast injection.