Indication for Use
The BENCHMARK Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Contraindications
There are no known contraindications.
Warnings
• The BENCHMARK Intracranial Access System should only be used by physicians who have received appropriate training in interventional techniques.
• The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location; and/or may compromise the structural integrity of the device.
• Do not use automated high-pressure contrast injection equipment with the Benchmark Intracranial Access System because it may damage the device.
• 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
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.
• Use prior to the “Use By” date.
• Use the BENCHMARK Intracranial Access System in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the BENCHMARK Intracranial Access System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Unrestrained moving or torquing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of an appropriate flush solution
• If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device
• Prior to beginning radial artery access, conduct screening, such as an Allen test, to ensure that radial access is appropriate for the patient.
• As in all fluoroscopy procedures, consider all necessary precautions to limit patient radiation exposure by using sufficient shielding, reducing fluoroscopy times and modifying radiation technical factors whenever possible.
• 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.
Potential adverse events
Possible complications include, but are not limited to, the following:
acute occlusion; air embolism; death; distal embolization; emboli; false aneurysm formation; access site complications such as hematoma, inflammation, infection, necrosis, pain and tenderness, granuloma; infection; intracranial hemorrhage; ischemia; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; radial artery spasm, radial artery occlusion and compartment syndrome; radiation exposure may lead to cataracts, skin reddening, burns, alopecia, or neoplasia; hand dysfunction; pathological hand cold intolerance
Indication For Use
The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Contraindications
There are no known contraindications.
Warnings
The Neuron Intracranial Access System should only be used by physicians who have received appropriate training in interventional techniques.
Precautions
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location; and/or may compromise the structural integrity of the device.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.
• Use prior to the “Use By” date.
• Use the Neuron Intracranial Access System in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the Neuron Intracranial Access System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Unrestrained moving or torquing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of an appropriate flush solution.
• If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
acute occlusion; air embolism; death; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at puncture site; infection; intracranial hemorrhage; ischemia; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation.
