Contraindications - COOK Medical Kumpe Gebrauchsanweisung

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KUMPE ACCESS CATHETER
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed
practitioner). Please read all instructions before using this device.
DEVICE DESCRIPTION
The Kumpe Access Catheter is composed of a polymer reinforced with a stainless steel braided wire. The proximal
end has a Luer lock hub, and the distal end is formed into an angle shape. The catheter is 65 cm long and is 5.0 Fr in
diameter.
NOTE: The Kumpe Access Catheter can accept up to .038 inch in diameter wire guides.
INTENDED USE
These devices are intended for access and catheterization of the urinary tract, including the following applications:
• Delivery of contrast media
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides

CONTRAINDICATIONS

This device is contraindicated for use in patients unsuitable for catheterization.
WARNINGS
Sterilized by Ethylene Oxide gas. Do not use if sterile barrier is damaged. The device is intended for one-time use.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in ureteral access techniques. Standard
techniques should be employed.
• Avoid bending or kinking the catheter prior to placement. Doing so could damage the integrity of the catheter
and result in patient injury.
• If you encounter resistance while advancing or withdrawing the catheter, stop. Determine the cause of the
resistance before proceeding.
• Do not withdraw the catheter while it is deflected in the cystoscope/endoscope.
POTENTIAL ADVERSE EVENTS
Adverse events that may result from catheter placement include, but are not limited to:
• Extravasation
• Hemorrhage
• Sepsis
• Edema
• Loss of renal function
• Perforation or laceration of the kidney, renal pelvis, ureter, and/or bladder
• Peritonitis
• Urinary tract infection
• Abrasion
INSTRUCTIONS FOR USE
Placement with a Wire Guide
1. Place the cystoscope within the bladder to locate the ureteral orifice.
2. Flush the catheter of choice.
3. Advance the catheter through the cystoscope and into the bladder.
2