Contraindications - COOK Medical Universa Gebrauchsanweisung

UNIVERSA® SOFT URETERAL STENTS AND STENT
SETS
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
The Universa Soft Ureteral Stents and Stent Sets are flexible tubular devices
made from radiopaque polyurethane. The stents are available with or without
hydrophilic coating. Each end of the Universa Soft Ureteral Stent consists
of a curled, tapered pigtail. Sideports are placed on each end of the stent,
including on the pigtails of the stent. A braided or monofilament tether for
repositioning and removal of the device is located on the proximal pigtail of
the stent. Radiopaque graduation marks are located on the stent to increase
fluoroscopic visualization during stent advancement and placement.
The Universa Soft Ureteral Stent Set includes (set components may vary):
• Radiopaque double pigtail stent
• Stainless steel wire guide
• Radiopaque stent positioner with radiopaque tip
• Pigtail straightener
INTENDED USE
The Universa Soft Ureteral Stents and Stent Sets are used for temporary
internal drainage from the ureteropelvic junction to the bladder. Ureteral
stents have been used to relieve obstruction in a variety of benign, malignant
and post-traumatic conditions. The stents may be placed using endoscopic,
percutaneous or open surgical techniques.

CONTRAINDICATIONS

None known
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.
• After use this device may be a potential biohazard. Handle and dispose of
in accordance with acceptable medical practices and with applicable local,
state and federal laws and regulations.
PRECAUTIONS
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
the reproductive and developmental effects.
• The Universa Soft Stents must not remain indwelling more than six
months. If the patient's status permits, the stent may be replaced with a
new stent.
• These stents are not intended as permanent indwelling devices.
• The tether should be removed if the stent is to remain indwelling
longer than 14 days.
• Do not force components during removal or replacement. Carefully
remove the components if any resistance is encountered.
• A pregnant patient must be more closely monitored for possible stent
encrustation due to calcium supplements.
• Improper handling can seriously weaken the stent. Acute bending or
overstressing during placement may result in subsequent separation of the
stent at the point of stress after a prolonged indwelling period.
• Angulation of the wire guide or stent should be avoided. Use of a 0-degree
scope lens is recommended. Scopes larger than 21.0 French are suggested.
• Individual variations of interaction between stents and the urinary system
are unpredictable.
• Ureteral stents should be checked periodically for signs of encrustation
and proper function. Periodic checks of the stent by cystoscopic and /
or radiographic procedures are recommended at intervals deemed to be
appropriate by the physician in consideration of the individual patient's
condition and other patient specific factors. The stent is not intended as a
permanent indwelling device which should not exceed 180 days.
• Use of the device should be based upon consideration of risk-benefit
factors as they apply to your patient.
POTENTIAL ADVERSE EVENTS
Complications of ureteral stent placement are documented. These
complications include, but are not limited to:
• Extravasations
• Occlusion
• Migration
• Hemorrhage
• Sepsis
• Perforation of the urinary tract
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ENGLISH