RFX072-105-08

Indications, Safety, and WarningsCautionFederal law (United States) restricts this device to sale, distribution, and use by or on the order of a physician.Indications for useThe Navien™ intracranial support catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.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™ 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™ 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™ intracranial support catheter, guide wire, and catheter sheath introducer).

ContraindictionsThere are no known contraindications.CompatibilityRefer to product label for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.Potential complicationsPotential 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 deficit including stroke

Vessel spasm, thrombosis, dissection, or perforation

Warnings

The Navien™ 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.

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at www.medtronic.com/manualsUS-NNP-2400088 (v1.0)

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