ProStar XL Manual Del Usuario página 6

tecHnIQue for neeDLe BAcK-DoWn
The following describes a safety feature ("needle back-
down") that permits the physician to return the needles into
the sheath . This feature provides the option of exchanging
the Prostar XL device with another Prostar XL device or an
introducer sheath so that the patient may be treated with
conventional compression therapy .
1 . If resistance to counterclockwise rotation of the handle
is felt, do not attempt to deploy the needles. Check
that the interlocks are correctly aligned with the locking
indents in the hub . The star on the edge of the hub
should be centered directly between the interlocks .
2 . If the needles are not easily deployed, back the needles
down into the sheath prior to removal of the device .
3 . Manually remove the coiled sections of the suture
lumens to uncover the suture loops .
4 . Use a hemostat to grasp the pull rod close to the hub .
Advance the pull rod 1 cm into the core (see figure 7)
and then gently pull the slack out of the uncovered
suture loops .
5 . Repeat step 4 until the handle snaps into position on the
proximal end of the device .
6 . Pull back on the suture loops exiting the suture
lumens to ensure that all slack in the sutures has been
removed .
7 . Prior to device removal, use fluoroscopy to verify the
needle has been returned to the needle guide . the
needle tips should be as close as possible to the
proximal edge of the radiopaque sheath ring before
removal of the Prostar XL device.
8 . Perform the same "needle back-down" procedure in
the event that all needles are not deployed . Do not
reMoVe AnY DePLoYeD neeDLes.
9 . Do not attempt to re-deploy the Prostar XL device after
the needles have been "backed-down" . Replace the
Prostar XL device with another Prostar XL device, an
introducer sheath or use conventional compression
therapy .
suture BreAKAGe
1 . If suture breakage occurs prior to completing the initial
knot, discard the suture material and remove the device
over the guide wire . Use another Prostar XL PVS device
to complete the procedure or replace the introducer
sheath .
2 . If the sutures are inadvertently tangled or removed prior
to knot tying, discard the suture material and remove
the Prostar XL device over the guide wire . Use another
Prostar XL device to complete the procedure .
3 . If suture breakage occurs after an initial knot has been
tied, another Prostar XL device may be introduced or the
introducer sheath may be replaced . If replacement of the
introducer sheath is attempted, care should be taken to
avoid excessive force during introduction . Any resistance
to introduction should result in advancement of an
introducer sheath small enough to be introduced without
undue force, but large enough to maintain hemostasis .
RELEASED
figure 7
neeDLe GuIDe BreAK ProceDure
The following describes a safety procedure that allows the
physician to remove the Prostar XL device from the patient
without surgical intervention, in the event that the Needle
Guide of the Prostar XL device breaks .
Procedure for needle Guide Break pre needle
deployment:
1 . Do not advance or withdraw the Prostar XL device
against resistance until the cause of that resistance
has been determined . Advancing or withdrawing the
Prostar XL device against resistance may cause the
device to break.
note: though the guide will appear to be broken, the
2 .
sheath remains attached to the device via the holder
stop . The Prostar XL device has a redundant system that
prevents the sheath from becoming completely detached
from the device .
3 . To remove a Prostar XL device with a Needle Guide
Break that occurred during device insertion, evaluate if
the Guide Wire Exit Port can be visualized above the
skin .
4 . If the Guide Wire Exit Port cannot be visualized:
4 .1 . Manually remove the coiled sections of the suture
lumens to uncover the suture loop .
4 .2 . Pull back on the suture loops exiting the suture
lumens to ensure that all slack in the sutures has
been removed .
4 .3 . Clamp the suture lumens with hemostats .
4 .4 . Remove the device until the Guide Wire Exit Port
is visualized .
5 . Insert a 0 .038" (0 .97 mm) (or smaller) guide wire into
the Guide Wire Exit Port and replace the Prostar XL
device with another Prostar XL device, an introducer
sheath, or use conventional compression therapy . If a
guide wire straightener is used to reinsert the guide wire,
care must be taken to avoid disturbing the hemostasis
valve located in the device just distal to the guide wire
exit port .
Procedure for needle Guide Break post needle deployment:
1 . Do not compress the femoral access site while
withdrawing the Prostar XL device from the tissue tract .
Applying excessive force to the Prostar XL sheath,
due to site compression, during removal of the device
may result in a needle guide break.
Do not tighten the suture around the sheath . tightening
2 .
the suture around the sheath during Prostar XL device
removal may result in a needle guide break.
3 . Do not advance or withdraw the Prostar XL device
against resistance until the cause of that resistance
has been determined . Advancing or withdrawing the
Prostar XL device against resistance may cause the
device to break.
4 . note: though the guide will appear to be broken, the
sheath remains attached to the device via the holder
stop . The Prostar XL device has a redundant system that
prevents the sheath from becoming completely detached
from the device .
5 . To remove the Prostar XL device when a Needle Guide
Break has occurred during device removal, evaluate if
the Guide Wire Exit Port can be visualized above the
skin .
5 .1 . If the Guide Wire Exit Port cannot be visualized,
apply similar and simultaneous backward tension
to both the circular handle and the device hub .
5 .2 . Remove the device until the Guide Wire Exit Port
is visualized .
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