Potential Complications - COOK Medical Cotton-Leung Sof-Flex CLSO-SF-7-5 Instructions For Use Manual

ENGLISH
INTENDED USE
This device is used to drain obstructed biliary ducts.
NOTES
This device is designed for single use only. Attempts to reprocess, re-sterilize, and/or
reuse may lead to device failure and/or transmission of disease.
Do not use this device for any purpose other than stated intended use.
If the 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. Notify Cook for return authorization.
This device must be stored in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
For 10 FR Sof-Flex® stents, lubricate the guiding catheter with water-soluble lubricant.
Retain the positioning sleeve for use when introducing the stent flaps into the accessory
channel.
CONTRAINDICATIONS
Those specific to ERCP and any procedure to be performed in conjunction with stent
placement.
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.
Those associated with biliary stent placement include, but are not limited to: trauma to
the biliary tract or duodenum, obstruction of the pancreatic duct, stent migration.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
This stent must be placed under fluoroscopic monitoring.
The positioning sleeve is not intended for use in the accessory channel of the
endoscope.
The tapered tip end of the stent and side hole must be positioned in the common bile
duct while the other end remains in the duodenum.
This device should not be left indwelling for more than three months or as directed by a
physician. Periodic evaluation is recommended.
Select the Cook stent introducer system in the appropriate French size.
These symbols from the package label indicate the following:
Not compatible with Fusion Wire Guide Locking device.
Use with FS-OA-10 or PC-10 and GC-5.
Sphincterotomy is not required for device placement.
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