COOK Medical Universa Gebrauchsanweisung Seite 3

UNIVERSA® FIRM 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 Firm Ureteral Stents and Stent Sets are flexible tubular devices made from radiopaque polyurethane,
with hydrophilic coating. Each end of the Universa Firm Ureteral Stent consists of a curled 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. Graduation marks are located on the stent to
provide visualization during stent advancement and placement.
The Universa Firm Ureteral Stent Set includes (set components may vary):
• Radiopaque double pigtail stent with tether
• Stainless steel wire guide with PTFE coating
• Stent positioner with radiopaque tip
• Pigtail straightener
INTENDED USE
The Universa Firm 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.
Universa Firm Stents are not intended to remain indwelling more than twelve months.
CONTRAINDICATIONS
None known
WARNINGS
• 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.
• 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
• 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.
• 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 twelve months.
• Use of the device should be based upon consideration of risk-benefit factors as they apply to your patient.
3
ENGLISH