Scepter C™ & Scepter XC™ Indications, Safety, and Warnings

Warnings and Precaution

Warnings:

• Verify the size of the vessel under fluoroscopy. Ensure that the balloon catheter is appropriate for the size of the vessel.

• Do not exceed the maximum recommended inflation volume as balloon rupture may occur.

• The balloon catheter has been tested for compatibility or use with liquid Onyx™ Liquid Embolic System and DMSO. For all other liquid embolics, refer to their Instructions For Use.

• The balloon catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

• Viscosity and concentration of contrast will affect balloon inflation and deflation times.

• During preparation, do not deflate the balloon unless the distal tip is submerged in saline or contrast to prevent air from entering balloon.

• Do not attach any high pressure devices to the balloon inflation port as this may rupture the balloon.

• Do not inflate the balloon with air or any other gas while in the body.

• Improper preparation may introduce air into the system. The presence of air may inhibit proper fluoroscopic visualization.

• Excessive pressure higher than 700 PSI (4826kPa, 47.6atm) may cause leakage or rupture of the balloon catheter guidewire lumen.

• When air-purging the balloon catheter, inject fluid slowly otherwise balloon rupture may occur.

• If back-loading the balloon catheter over a guidewire, ensure distal tip of the balloon catheter is not damaged.

• Do not over-tighten the RHV around the balloon catheter. Over-tightening could delay balloon inflation and deflation.

• Do not advance the balloon catheter or guidewire against resistance. If resistance is felt, assess the source of resistance using fluoroscopic means.

• Always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.

• The shaping mandrel is not intended for use inside the body. Ensure shaping mandrel is removed from balloon catheter prior to introduction into the RHV or other accessories.

• NBCA and solutions containing ethyl esters of iodized fatty acids of poppy seed oil are not compatible with the balloon.

Precautions:

• After balloon preparation for use and prior to use, re-inflate to nominal volume and inspect for any irregularities or damage. Do not use if any inconsistencies are observed.

• Verify balloon catheter compatibility when using other ancillary devices commonly used in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.

• The balloon catheter has a lubricious surface and should be hydrated prior to use. Once the balloon catheter is hydrated, do not allow it to dry.

• Protect the balloon when tip steam shaping or purge hole sealing of the balloon catheter as it may affect the integrity of the balloon material.

• Exercise care in handling the balloon catheter to reduce the chance of accidental damage.

• With the exception of dimethyl sulfoxide (DMSO), use of other organic solvents may damage the balloon catheter and/or coating on the surface.

• Verify that the diameter of any guidewire or accessory device used is compatible with the inner diameter of the balloon catheter prior to use.

• Take precaution when manipulating the balloon catheter in tortuous vasculature to avoid damage. Avoid advancement or withdrawal against resistance until the cause of resistance is determined.

• Presence of calcifications, irregularities or existing devices may damage the balloon catheter and potentially affect its insertion or removal.

• Always verify proper balloon vessel occlusion prior to and during embolic material delivery. Sealing the purge hole prior to embolic material delivery may provide assistance during use.

• Excessive torque applied to the syringe might result in damage to the Scepter hub assembly.

• Continuing negative aspiration after the balloon is fully deflated will result in blood entering the balloon and will reduce fluoroscopic visibility.