Scepter™ Mini 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 Onyx™ Liquid Embolic System and DMSO. For all other liquid embolic, 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 use click activated flow control switch, such as FloSwitch™ with the balloon catheter.

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.

Do not over-tighten the RHV around the balloon catheter. Over-tightening could damage the catheter shaft and 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.

n-BCA (n-butyl cyanoacrylate) 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 for at least 30 seconds prior to use. Once the balloon catheter is hydrated, do not allow it to dry.

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.

DMSO-based embolization materials should only be used in accordance with their neurovascular approved indications for use.

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.

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

Exercise necessary precautions to limit X-radiation doses to patients and operators by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.