Precautions; Adverse Events - Boston Scientific IMAGER II Gebrauchsanweisung

• Do not exceed the pressure ratings printed on the device
labeling. Catheter integrity may be compromised if pressure
limits are exceeded.
• The risk associated with IMAGER II
Catheters outside the intended use is not known.

PRECAUTIONS

• Carefully inspect the catheter prior to use to verify that the
size and shape are suitable for the specified procedure and
that no damage has occurred during shipment.
• Extreme care must be taken when selecting and using the
Imager II Angiographic Catheters to avoid damage to the
vessel walls through which this catheter passes.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
• Use prior to the "Use By" date.
• Non-pyrogenic.
• Store in a cool, dry, dark place.
• To facilitate the introduction of the catheter and avoid
damage to the puncture site, the catheter should be
introduced through an introducer sheath and over an
appropriate guide wire.
• The IMAGER II Angiographic Catheters are designed for
use with specific guide wire diameters. The recommended
maximum guide wire diameter is provided on the
catheter label.
• Guide wire use has been associated with a higher
incidence of thrombus formation. Optimal guide wire
diameter and judicious use are recommended.
• Precautions to prevent or reduce clotting should be taken
when any catheter is used in the vascular system. The
catheter should always be filled with either heparinized
saline solution or contrast medium. Use of systemic
heparinization should be considered.
• If resistance is encountered during catheter manipulation,
determine the cause under fluoroscopy and take the
necessary remedial action.
• If resistance is encountered when removing the guide wire
from the catheter, simultaneously remove the catheter and
the guide wire as a single unit under fluoroscopy to prevent
potential damage to the vessel and/or product damage.
• Any use of these devices, other than those indicated in the
instructions is not recommended.
• The IMAGER II Angiographic Catheters are clinically
hydratable and the effective length may increase up to
4.5 mm after hydration. There is no effect on the outer
diameter of the catheter during hydration.

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be
associated with the use of angiographic catheters include but
are not limited to:
• Access Site Related Trauma
• Arteriovenous Fistula
• Embolism
• Hemorrhage
• Infection
• Ischemia
• Neurological Deficit Including Stroke
• Plaque Dislodgment
• Pseudoaneurysm
• Thrombus Formation
• Vasospasm
Black (K) ∆E ≤5.0
Angiographic
™
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