Standard Glidewire^® Guidewire

Prescriptive Information

The Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.

Contraindications

No contraindications are known.

Warnings

For single use only. Do not reuse, reprocess or resterilize. Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in destruction and/or separation of the device, which may result in injury. Do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.

Potential Adverse Effects

The Potential Complications, which may result from the use of a guidewire in urological guidewire procedures, include perforation of the urinary tract, hemorrhage, edema, acute bleeding, and tissue trauma.

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. Do not use the guidewire if it becomes damaged to do so will prevent accurate torque or tactile response and may cause injury.

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

Trademark

Glidewire is a registered trademark of Terumo Corporation.