Abbott Prostar XL Mode D'emploi page 3

damage and / or breakage of the device, which may
necessitate intervention and / or surgical removal of
the device and vessel repair.
9 . If excessive resistance in advancing the Prostar XL
PVS device is encountered, withdraw the Prostar XL
device over a 0 .038" (0 .97 mm) (or smaller) guide wire
and reinsert the introducer sheath, or use conventional
compression therapy .
10 . In the event suture breakage occurs after an initial knot
has been tied, care should be taken to avoid excessive
force if the reintroduction of another Prostar XL device
or introducer sheath is required . Any resistance to
introduction should result in advancement of an
introducer sheath small enough to be introduced without
undue force .
11 . If significant blood flow is present around the barrel
of the Prostar XL device, do not deploy the needles .
Remove the Prostar XL device over a 0 .038" (0 .97 mm)
(or smaller) guide wire and insert an appropriately sized
introducer sheath .
12 . Remove the Prostar XL sheath before tightening the
suture . Failure to remove the sheath prior to tightening
the suture may result in detachment of the tip of the
sheath .
13 . In using this or any other suture material, care should
be taken to avoid damage from handling . Avoid crushing
damage due to application of surgical instruments such
as forceps or needle holders .
14 . Do not attempt to re-deploy Prostar XL needles after the
needles have been "backed-down" into the sheath (refer
to the tecHnIQue for neeDLe BAcK-DoWn section) .
15 . If using the "pre-close" technique (placement of the
Prostar XL device sutures prior to dilating the access
site beyond 10F), sutures should be gradually tightened
as the introducer sheath is removed to maintain
hemostasis .
16 . Use conventional compression methods in the event
bleeding from the femoral access site persists, after the
use of the Prostar XL PVS device .
17 . The Prostar XL device should be advanced using
fluoroscopic guidance to prevent possible vessel
damage .
sPecIAL PAtIent PoPuLAtIons
The safety and effectiveness of the Prostar XL PVS System
have not been established in the following patient populations:
• Patients with introducer sheaths < 8 .5F or > 24F during
the catheterization procedure .
• Patients with ipsilateral arterial access sites punctured
and compressed within 48 hours of closure .
• Patients having arterial access in vessels other than the
common femoral artery .
• Patients having a hematoma, pseudoaneurysm or
arteriovenous fistula present prior to sheath removal .
• Patients with femoral artery calcium, which is
fluoroscopically visible at access site .
• Patients with small femoral arteries (< 5 mm in
diameter) .
• Patients with severe claudication, iliac or femoral artery
diameter stenosis greater than 50% or previous bypass
surgery or stent placement in the vicinity of access site .
• Patients with access sites in vascular grafts .
• Patients with prior intra-aortic balloon pump at access
site at any time prior .
• Patients with ipsilateral femoral venous sheath during the
catheterization procedure .
• Patients with whom there is difficulty inserting the
introducer sheath or greater than one ipsilateral arterial
puncture at the start of the catheterization procedure .
RELEASED
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cLInIcAL ProceDure
The following instructions provide technical direction but do
not obviate the necessity of formal training in the use of
Prostar XL PVS System . The techniques and procedures
described below are not intended as a substitute for the
operator's experience and judgment in treating any specific
patients .
examination and selection of Products
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2 .
3 .
4 .
Arterial Puncture considerations
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2 .
3 .
Prostar XL Device Placement
the following instructions detail the deployment sequence
to close the access site of a catheterization procedure
performed through an applicable sized sheath.
When utilizing a "pre-close" technique (placement of the
Prostar XL device sutures prior to dilating the access site
beyond 10F) refer to step 7 in the Suture Management section
for more information .
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2 .
3 .
4 .
3
Patients with intra-procedural bleeding around access
site .
Patients receiving glycoprotein IIb/IIIa inhibitors before,
during, or after the catheterization procedure .
Patients younger than 18 years of age .
Patients who are pregnant or lactating .
Patients with bleeding diathesis or coagulopathy .
Patients who are morbidly obese where less than one
third of the access needle is above the skin line .
Patients with active systemic or cutaneous infection or
inflammation .
Patients with access sites above the most inferior border
of the inferior epigastric artery (IEA) and / or above the
inguinal ligament based upon bony landmarks .
Patients with antegrade punctures .
The outer pouch packaging of the Prostar XL PVS
System provides the sterile barrier . After careful
inspection of the packaging to ensure there is no
damage to the sterile barrier, remove the device from
the package .
Exercise care during device handling to reduce the
possibility of accidental device breakage .
Exercise care when using additional surgical instruments
such as forceps, hemostats or needle holders during
device handling, to reduce the possibility of accidental
device breakage .
Verify marker port patency by flushing the lumen with
saline until the saline exits from the marker port . Do not
use the Prostar XL PVs device if the marker lumen is
not patent.
Puncture the anterior wall of the common femoral artery
at an angle of approximately 45 degrees .
Avoid sidewall or posterior wall femoral artery punctures .
Puncture locations are ideally located in the common
femoral artery below the level of the inguinal ligament
and above the common femoral artery bifurcation .
Prior to Prostar XL device placement, perform a femoral
angiogram through the introducer sheath to verify that
the access site is in the common femoral artery .
Evaluate the femoral artery site for size, calcium
deposits, and tortuosity, to avoid posterior wall suture
placement and possible ligation of the anterior and
posterior walls of the femoral artery .
Re-prep the access site, placing clean towels around
the access site, and wearing new sterile gloves prior
to handling the device and proceeding with the closure
procedure .
While the introducer sheath remains in place, use a
scalpel to slightly extend the incision and forceps to
dilate subcutaneous tissue .