COOK Medical NASAL BILIARY DRAINAGE SET, Instructions For Use Manual

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ENGLISH
NASAL BILIARY DRAINAGE SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of a
physician (or properly licensed practitioner).
INTENDED USE
The Nasal Biliary Drainage Set is intended for temporary endoscopic drainage of
the biliary duct through the nasal passage by use of an indwelling catheter.
DEVICE DESCRIPTION
Each set includes a drainage catheter, drainage connecting tube, nasal transfer
tube and a pigtail straightener (if supplied). The drainage catheter is radiopaque to
aid with fluoroscopic placement. Devices with a –RT suffix on their part numbers
contain radiopaque marker bands.
For the drainage catheters with preloaded pigtail straightener, the pigtail
straightener is intended to be used for straightening the pigtail prior to insertion of
drainage catheter into the accessory channel of endoscope.
The drainage connector on the drainage connecting tube is intended to be
connected to a drainage collection bag. In the middle of the drainage connecting
tube is a three way stopcock (See Fig. 5) which allows for a flow through the
drainage connecting tube during the procedure.
The nasal transfer tube enables the drainage catheter to be threaded through the
oral cavity and out through the nostril. (See Figs. 2-4)
The above symbol means the following: For Drainage Only. (See Fig. 1)
The above symbol means the following: OFF. (See Fig. 5)
CONTRAINDICATIONS
Contraindications include those specific to ERCP.
Contraindications of nasal biliary drainage include, but are not limited to: active
pancreatitis or other infection, coagulopathy, inability to pass a wire guide or
drainage catheter through the obstructed area, recent food ingestion, sepsis.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with ERCP include, but are not limited to:
allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or
arrest, cholangitis, hemorrhage, hypotension, infection, pancreatitis, perforation,
For Drainage Only
OFF
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