Contraindications - COOK Medical Peel-Away Einfuhrschleusen-Set Gebrauchsanweisung

PEEL‑AWAY INTRODUCER SET
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 Peel-Away Introducer Set consists of a
coaxial introducer assembly (Peel-Away sheath
and dilator). Sets may also contain a wire guide
in a size fitted to the endhole of the dilator and
may contain an access needle in a gauge that
allows the included wire guide to pass through
its lumen.
INTENDED USE
The Peel-Away Introducer Set is intended for the
percutaneous introduction of balloon, electrode
and closed or non-tapered end catheters into
central and peripheral vasculature, and for
nonvascular use.

CONTRAINDICATIONS

Patient has a known or suspected obstruction
in the vessel.
RELATIVE CONTRAINDICATIONS
During gastroenterologic procedures:
• Ascites
• Colonic interposition
• Portal hypertension
• Gastric varices
• Peritonitis
• Morbid obesity
During pulmonologic procedures:
• Severe chronic lung disease (may increase risk
of pneumothorax)
• Irradiation to the anterior chest (may result in
poor healing)
WARNINGS
• Do not alter this device in any way.
• Do not withdraw the wire guide through a
metal needle; the wire guide may shear or
unravel.
• Aspiration pneumonia may result from feeding
tube placement.
PRECAUTIONS
• The wire guide in the Peel-Away Introducer
Set should not be withdrawn through the
needle once it has been placed beyond the
needle tip.
• This product is intended for use by clinicians
trained and experienced in diagnostic and
interventional techniques.
• If you encounter resistance during wire guide
or catheter manipulation, stop and determine
the cause before proceeding further.
NOTE: If you encounter resistance during
insertion, do not force the device.
• The maximum diameter of the instrument
or catheter to be introduced should be
determined to ensure its passage through the
introducer.
• When inserting, manipulating, or withdrawing
a device through an introducer, always
maintain introducer position.
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