Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
Indication For Use
The Penumbra Coil System is indicated for the embolization of:
• Intracranial aneurysms.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature.
Contraindications
There are no known contraindications.
Warnings
The Penumbra Coil System should only be used by physicians who have received appropriate training in neuro-interventional techniques.
Precautions
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may compromise the structural integrity of the device or increase the risk of contamination or infection leading to device failure and/or cross-infection and potential patient injury, illness, or death.
• Do not use kinked or damaged devices. Do not use opened or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.
• Use prior to the “Use By” date.
• Use device in conjunction with fluoroscopic guidance.
• Do not advance or retract the device against resistance without careful assessment of the cause using fluoroscopy.
• 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.
Potential Adverse Events
Possible complications include, but are not limited to, the following: acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation.
Indication For Use
The Penumbra Delivery Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.
Contraindications
There are no known contraindications.
Warnings
The Penumbra Delivery Microcatheters should only be used by physicians who have received appropriate training in interventional techniques.
Precautions
• The devices are 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 location.
• 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 Penumbra Delivery Microcatheters in conjunction with fluoroscopic visualization.
• Do not advance or withdraw the Penumbra Delivery Microcatheters against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. 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; hematoma or hemorrhage at access site; death; intracranial hemorrhage; hemorrhage; infection (at access site); distal embolization; ischemia (cardiac and/or cerebral); embolus (air, foreign body, thrombus, plaque); aneurysm perforation; false aneurysm formation; neurological deficits including stroke; vessel spasm, thrombosis, dissection, perforation or rupture; air embolism; emboli.
