COOK Medical Sof-Flex Mode D'emploi page 3

SOF-FLEX® MULTI-LENGTH URETERAL STENT SET
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
Set Contains:
• Radiopaque stent
• Stent positioner
• Appropriate diameter stainless steel wire guide
NOTE: The multi-length stents will accommodate ureters from approximately 4 - 32 cm long.
NOTE: Set components may vary.
RECOMMENDED WIRE GUIDE
Stent Size
3.0 French
4.7 French
6.0 French
7.0 French
INTENDED USE
The Sof-Flex Multi-Length Ureteral Stent Set is intended for temporary internal drainage from the ureteropelvic
junction to the bladder. Sof-Flex Multi-Length Ureteral Stent Sets have been employed to relieve obstruction in
a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic,
percutaneous, or open surgical techniques.
3 French stents are indicated for pediatric patients.
CONTRAINDICATIONS
• Do not attempt stent placement in a patient with suspected ureteral avulsion,
• Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of
the patient.
WARNINGS
Formation of knots in multi-length stents may occur. This may result in injury to the ureter during removal and/or
the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is
encountered during attempts at removal.
PRECAUTIONS
• Manipulation of the wire guide requires appropriate imaging control. Use caution not to force or overmanipulate
the wire guide when gaining access.
• When using a wire guide through a metal cannula/needle, use caution as damage may occur to the outer coating.
• When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place
under fluoroscopy in order to avoid unexpected wire guide displacement.
• These wire guides are not intended for PTCA use.
• Complications of ureteral stent placement are documented in literature. Use of this device should be based
upon consideration of risk-benefit factors as they apply to your patient. Informed consent should be obtained to
maximize patient compliance with follow-up procedures.
Accepts Wire Guide
.018 inch
.035 inch
.038 inch
.038 inch
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ENGLISH