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Device Description; Intended Use; Contraindications - COOK Medical Evolution RL Gebrauchsanweisung

Dilatatorschleusen-set mit kontrollierter rotation
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Cook Vascular Incorporated
Evolution® RL Controlled-Rotation Dilator Sheath Set
Instructions for Use

DEVICE DESCRIPTION

The Evolution RL Controlled-Rotation Dilator Sheath Set is comprised
of an inner polymer sheath connected to a handle capable of
mechanically rotating the sheath and an outer telescoping polymer
sheath. The inner sheath has a stainless steel tip at its distal end.

INTENDED USE

The Evolution RL Controlled-Rotation Dilator Sheath Set is intended
for use in patients requiring the percutaneous dilation of tissue
surrounding cardiac leads, indwelling catheters and foreign objects.
Sheath Size
9 Fr
11 Fr
13 Fr
Use With Other Devices
The Evolution RL Controlled-Rotation Dilator Sheath Set may be
used in conjunction with the following catheter/lead extraction
devices from COOK Vascular Incorporated:
Locking Stylet
Lead Extender
Be sure to closely follow the "Suggested Instructions for Use" for
each device used.

CONTRAINDICATIONS

None known
WARNINGS
When using sheaths, do not insert sheaths over more than
one lead at a time. Severe vessel damage, including venous wall
laceration requiring surgical repair, may occur.
When using a Locking Stylet:
Do not abandon a catheter/lead in a patient with a Locking
Stylet still in place inside the catheter/lead. Severe vessel
or endocardial wall damage may result from the stiffened
catheter/lead or from fracture or migration of the abandoned
stylet wire.
Do not apply weighted traction to an inserted Locking Stylet
as myocardial avulsion, hypotension, or venous wall tearing
may result.
Be aware that a lead that has a J-shape retention wire that
occupies its inner lumen (rather than being outside the coil)
may not be compatible with the Locking Stylet. Insertion of the
Locking Stylet into such a lead may result in protrusion and
possible migration of the J-shape retention wire.
Weigh the relative risks and benefits of intravascular catheter/
lead removal procedures in cases when:
The item to be removed is of a dangerous shape or
configuration,
The likelihood of catheter/lead disintegration resulting in
fragment embolism is high or vegetations are attached directly
to the catheter/lead body.
Catheter/lead removal devices should be used only at
institutions with thoracic surgical capabilities.
Catheter/lead removal devices should be used only by
physicians knowledgeable in the techniques and devices for
catheter/lead removal.
Federal law restricts this device to sale by or on the order
of a physician.
LR-EVN-9.0-RL
LR-EVN-11.0-RL
LR-EVN-13.0-RL
Sheath Set
2

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