COOK SteadySheath Evolution Instrucciones De Uso página 3

When advancing sheaths including the Evolution device and/
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or SteadySheath Tissue Stabilization Sheath, use proper sheath
technique and maintain adequate tension on the catheter/lead (via
a Locking Stylet or directly) to avoid damage to vessel walls.
Excessive force with sheaths (including the Evolution
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device and/or SteadySheath Tissue Stabilization Sheath) used
intravascularly may result in damage to the vascular system
requiring surgical repair.
Evolution Shortie or Evolution Shortie RL should only be used
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to minimally enter the vessel. Do not attempt to negotiate the
Evolution Shortie or Evolution Shortie RL device past a bend in the
vessel as vessel wall or cardiac lead insulation damage may occur.
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.
As a result of the risk of complications, doctors highly experienced in
this procedure have advised the following:
PREPARATIONS
• Obtain a thorough patient history, including patient blood type.
Appropriate blood products should be rapidly available.
• Ascertain the manufacturer, model number, and implant date of
the catheter/lead to be removed.
• Perform radiographic/echocardiographic evaluation of catheter/
lead condition, type, and position. Use a procedure room that
has high quality fluoroscopy, pacing equipment, defibrillator,
thoracotomy tray, and pericardiocentesis tray.
• Echocardiography and cardiothoracic surgery should be rapidly
available.
• Prep/drape the patient's chest for possible thoracotomy; prep/
drape the patient's groin for femoral approach or possible femoral
approach.
• Establish back up pacing as necessary.
• Have available an extensive collection of sheaths, Lead Control
Devices (Locking Stylet and Lead Extender), stylets to unscrew
active fixation leads, snares, and accessory equipment.
PROCEDURE
• Use fluoroscopic monitoring during ALL catheter/lead and
sheath manipulations. Monitor ECG and arterial blood pressure
continuously throughout the procedure and during recovery.
• If using sheaths or sheath sets, including the Evolution device
and/or the SteadySheath Tissue Stabilization Sheath, the following
precautions should be followed:
• Prior to using sheaths including the Evolution device or
SteadySheath it is essential to carefully inspect the extravascular
catheter/lead tract to ensure removal of all suture sleeves, sutures,
and tie-down materials.
• The Evolution Shortie, Evolution Shortie RL or Byrd Telescoping
Stainless Steel Dilator Sheath Set should be used only to
minimally enter the vessel.
• Be aware that insertion of a Byrd Telescoping Stainless Steel
Dilator Sheath Set over a Byrd Dilator Sheath Set Polypropylene or
the Evolution device may damage the inner sheath.
• If excessive scar tissue or calcification prevents safe
advancement of sheaths, consider an alternate approach.
• If the catheter/lead breaks, evaluate fragment; retrieve as
indicated.
• If hypotension develops, rapidly evaluate; treat as appropriate.
• Due to rapidly evolving catheter/lead technology, this device may
not be suitable for the removal of all types of catheters/leads. If there
are questions or concerns regarding compatibility of this device with
particular catheters/leads, contact the catheter/lead manufacturer.
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