Potential Adverse Events - COOK SteadySheath Evolution Instrucciones De Uso

POTENTIAL ADVERSE EVENTS

Potential adverse events related to the procedure of intravascular
extraction of catheters/leads include (listed in order of increasing
potential effect):
dislodging or damaging nontargeted catheter/lead
chest wall hematoma
thrombosis
arrhythmias
acute bacteremia
acute hypotension
pneumothorax
stroke
migrating fragment from catheter/object
pulmonary embolism
laceration or tearing of vascular structures or the myocardium
hemopericardium/pericardial effusion
cardiac tamponade
hemothorax
cardiac arrest
death
INSTRUCTIONS FOR USE
Suggested Instructions for Use
SteadySheath Evolution Tissue Stabilization Sheath
1. Surgically expose the proximal end of the indwelling catheter/lead
and remove the catheter/lead from its connections (if connected).
Remove all suture and tie-down materials.
2. Cut off all proximal fittings, if present, using clippers or other cutters.
It is important to cut the catheter/lead very close to the connector
(but past any crimp joints) leaving as long a portion of the indwelling
catheter/lead to work with as possible. Avoid closing off the interior
lumen (or coil) of the catheter/lead when cutting it.
3. Unless the catheter/lead insulation is damaged, degraded or too
thin, tie a ligature or affix a compression coil (Cook) at the proximal end
of the catheter/lead, compressing the insulation against the coil and
Locking Stylet to help prevent the coil and insulation from stretching.
The ligature can be tied to the loop handle or to the suture tie loop.
NOTE: If a Locking Stylet has not been used, be aware that
damage to the catheter/lead caused by pulling on it may prevent
subsequent passage of a Locking Stylet through the lumen and/or
make dilation of scar tissue more difficult.
4. For an active fixation catheter/lead, attempt to unscrew the catheter/
lead by rotating the catheter/lead and Locking Stylet counterclockwise
if appropriate.
5. Gently pull back on the catheter/lead to see if it is still engaged in
tissue. If the catheter/lead is sufficiently loose in the tissue, gently pull
on the Locking Stylet and catheter/lead to remove it.
6. If the catheter/lead is not removed from the vessel with gentle
pulling then using dilator sheaths, including the Evolution device,
Evolution Shortie device, SteadySheath or other retrieval devices may
help separate the catheter/lead from tissue encapsulation as follows:
Advance dilator sheaths (or other retrieval device) over the proximal
wire extender of the Locking Styet (if applicable).
7. With the SteadySheath placed outside the appropriate inner sheath
for telescopic action, insert the proximal free end of the catheter/lead
with Locking Stylet in place, into the distal end of the inner Evolution
device or Evolution Shortie device. Advance the catheter/lead until it
completely exits the opposite (proximal) end of the sheath set.
8. Apply adequate retracting pressure or tension on the catheter/
lead and/or its wire guide or Locking Stylet (if used). This is critical
to safe passage of the sheath set over the catheter/lead. If tension is
inadequate, the catheter/lead may buckle, precluding the sheath set
from advancement along the appropriate path.
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