Gemini™ Paired Wire Helical Baskets

Prescriptive Information

The Urological Retrieval Devices are intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.

Contraindications

Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.

Warnings

For single use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a laser or lithotripter; to do so may damage the device and could result in patient injury.

Potential Adverse Effects

The potential complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, and inability to disengage from irretrievable object, edema, and basket inversion.

Cautions

Before using, inspect the sterile barrier for any breach of the package to ensure a sterile product and inspect product for any damage. If seal has been broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific. If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE.

Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.