INTENDED USE

Fixed Core Wire Guides are intended to facilitate the placement of devices during diagnostic and interventional procedures.

CONTRAINDICATIONS

None known

WARNINGS

• This product is not intended for use in the coronary arteries .
• This product is a delicate instrument . Avoid forceful angulation
• Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula . A sharp edge may scrape or shear material from the wire guide
• Altering the tip's configuration or curve manually may damage the wire guide .

PRECAUTIONS

• This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques . Standard techniques for placement of devices in angiographic procedures should be employed.
• Do not attempt to torque the wire guide.
• Use medical imaging when you manipulate the wire guide . Do not advance or manipulate the wire guide without visual evidence of the corresponding movement of the distal tip
• When you use the wire guide with another device , consider the end-hole size and the length of the device in order to ensure a proper fit between the wire guide and the device .
• Do not advance or withdraw a wire guide when resistance is encountered as a perforation could occur .
• Use only the flexible end as the initial inserted end Inserting from the rigid end may cause damage to tissue or the device.
• Inspect the wire guide for kinks or damage prior to use .

Complications which can result from the use of guidewires in urological applications include:

• Perforation of the urinary tract

• Acute Bleeding

• Hemorrhage

• Tissue Trauma

• Edema

• Foreign Object in Body

• Infection

• Hemoglobinuria

• Peritonitis