Navien™ A+ Intracranial Support Catheter Indications, Safety, and Warnings

INDICATIONS FOR USE

The Navien A+ Intracranial Support Catheter is indicated for the introduction of interventional / diagnostic devices into the peripheral, coronary, and neuro vasculature.

The Navien A+ Intracranial Support Catheter is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from selected blood vessels in the arterial system, including neurovasculature.

CAUTION

• Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
• This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.

PRECAUTIONS

• Store in a cool, dry, dark place.
• Do not use kinked or damaged devices.
• Do not use open or damaged packages.
• Use prior to the “Use By” date.
• Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
• Use the Navien A+ Intracranial Support Catheter in conjunction with fluoroscopic visualization.
• Inspect the catheter system before use to verify that its size and condition are suitable for the specific procedure.
• Do not advance or withdraw Navien A+ Intracranial Support Catheter 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 appropriate flush solution.
• If flow through the catheter becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
• Extreme care must be taken to avoid damage to the vasculature through which the catheter passes. The catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
• Torquing the catheter may cause damage which could result in kinking and possible separation along the catheter shaft. Should the system become severely kinked, withdraw the entire system (Navien A+ Intracranial Support Catheter, guide wire and catheter sheath introducer).

CONTRAINDICATIONS

There are no known contraindications.

COMPATIBILITY

Refer to product label for device dimensions. Refer to labelling provided with other medical technologies to determine compatibility.

POTENTIAL COMPLICATIONS

Potential 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 haemorrhage
• ischemia
• neurological deficit
• including stroke
• vessel spasm, thrombosis, dissection or perforation

WARNINGS

• The Navien A+ Intracranial Support Catheter should only be used by physicians who have received appropriate training in interventional techniques. 
• Do not reuse. The device is intended for single use only. Discard the catheter after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.