Intended Use; Contraindications - COOK Medical Johlin IFU0098-1 Gebrauchsanweisung

ENGLISH

INTENdEd USE

This device is used to drain obstructed pancreatic ducts.
NOTES
Do not use this device for any purpose other than stated intended use.
If package is opened or damaged when received, do not use. Visually inspect with
particular attention to kinks, bends and breaks. If an abnormality is detected that
would prohibit proper working condition, do not use. Please notify Cook for
return authorization.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.

CONTRAINdICATIONS

Those specific to ERCP and any procedure to be performed in conjunction with
stent placement.
Additional contraindications include, but are not limited to: inability to dilate
stricture, inability to pass wire guide or stent through obstructed area.
POTENTIAL COMPLICATIONS
Those associated with ERCP include, but are not limited to: pancreatitis, cholangitis,
aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast
or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia
or arrest.
Other potential complications associated with pancreatic stent placement include,
but are not limited to: trauma to pancreatic duct or duodenum, obstruction of
common bile duct, stent migration.
WARNINGS
MRI compatibility of pancreatic stents has not been established.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
A complete diagnostic evaluation must be performed prior to use to determine
proper stent size.
This stent must be placed under fluoroscopic monitoring.
This stent must only be placed using introduction system provided with set.
This stent should not be left indwelling for more than three months or as directed
by a physician. Periodic evaluation is recommended.
INSTRUCTIONS FOR USE
Illustrations
1. Flush the injection port on the wedge stent introducer with sterile water or
saline.
3