Device Description; Intended Use - COOK Medical Evolution RL Instructions For Use Manual

ENGLISH
Evolution® RL Controlled-Rotation Dilator Sheath Set
Instructions for Use
Federal law restricts this device to sale by or on the order of a physician.

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:
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.
PRECAUTIONS
• Prior to the procedure, consider the size of the catheter/lead in relation to the size of the LEAD
EXTRACTION™ devices to determine possible incompatibility.
• If selectively removing catheters/leads with the intent to leave one or more chronic catheters/leads
implanted intact, the non-targeted catheters/leads must be subsequently tested to ensure that they were
not damaged or dislodged during the extraction procedure.
Sheath Set
LR-EVN-9.0-RL
LR-EVN-11.0-RL
LR-EVN-13.0-RL
2