Device Description; Indications For Use - ProStar XL Manual Del Usuario

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ProstAr XL
PercutAneous VAscuLAr surGIcAL (PVs) sYsteM
InstructIons for use
to ensure ProPer DePLoYMent AnD use of tHIs
DeVIce AnD to PreVent InJurY to PAtIents, reAD
ALL InforMAtIon contAIneD In tHese InstructIons
for use.
cAutIon
This device should only be used by physicians (or allied
healthcare professionals, authorized by, or under the direction of,
such physicians) who are trained in diagnostic and therapeutic
catheterization procedures and who have been trained by an
authorized representative of Abbott Vascular .
Prior to use, the operator must review the Instructions for Use
and be familiar with the deployment techniques associated
with the use of this device .

DeVIce DescrIPtIon

The Prostar XL Percutaneous Vascular Surgical (Prostar XL
PVS) device is designed to deliver polyester suture(s) to
close femoral artery puncture sites following catheterization
procedures . The Prostar XL device has two sutures and four
needles .
The Prostar XL device consists of a sheath, which contains
two pairs of sutured needles, a needle guide that precisely
controls the placement of needles around the puncture site
and a rotating barrel that receives deployed needles . The
Prostar XL sheaths have J-shaped tips at the distal end .
A marker lumen is contained within the barrel of the device
with the intra-arterial port of the lumen positioned in the
needle guide .
Proximally, the marker lumen exits from the hub of the device .
The marker lumen allows a pathway for back-bleeding from
the femoral artery and ensures proper device positioning .
The barrel rotates independently from the central core and is
designed to prepare the subcutaneous track . Barrel rotation
is accomplished by depressing the interlocks exiting from the
hub . The Prostar XL devices track over a standard 0 .038"
(0 .97 mm)(or smaller) guide wire .
The Prostar XL PVS System consists of a 10F Prostar XL
device and a Perclose Knot Pusher . The Perclose Knot
Pusher is designed to advance the tied suture knot to the
arteriotomy .
The Prostar XL device and the Perclose Knot Pusher are
depicted in figure 1 .
Prostar XL Percutaneous Vascular Surgical System
A. Prostar Device
B. Perclose Knot Pusher
Prostar XL Percutaneous Vascular Surgical System
A . Prostar device
B . Perclose Knot Pusher

InDIcAtIons for use

The Prostar XL Percutaneous Vascular Surgical Systems
are intended for percutaneous delivery of sutures for closing
the common femoral artery access site, reducing the time
to hemostasis and ambulation (patient walks ten feet/
three meters) for patients who have undergone catheterization
procedures .
The Prostar XL PVS System reduces the time to discharge
in patients having undergone diagnostic catheterization
RELEASED
figure 1
A .
A.
B .
B.
procedures without complicating clinical conditions (refer to
PRECAUTIONS and SPECIAL PATIENT POPULATIONS) .
The Prostar XL PVS System is designed for use in conjunction
with 8 .5 to 24F sheaths .
contrAInDIcAtIons
There are no known contraindications to the use of this
device . Attention is drawn to the Warnings, Precautions, and
Special Patient Populations .
WArnInGs
Do not use the Prostar XL PVS device or accessories if the
packaging or sterile barrier has been previously opened or
damaged, or if the components appear to be damaged or
defective .
DO NOT RESTERILIZE OR REUSE . The Prostar XL PVS
device and accessories are intended for single use only .
Do not use the Prostar XL PVS System if the sterile field has
been broken where bacterial contamination of the sheath or
surrounding tissues may have occurred, since such a broken
sterile field may result in infection .
Do not use the Prostar XL PVS System if the puncture site is
located above the most inferior border of the inferior epigastric
artery (IEA) and / or above the inguinal ligament based upon
bony landmarks, since such a puncture site may result in a
retroperitoneal hematoma . Perform a femoral angiogram to
verify the location of the puncture site .
Do not use the Prostar XL PVS System if the puncture is
through the posterior wall or if there are multiple punctures,
since such punctures may result in a retroperitoneal
hematoma .
Do not use the Prostar XL PVS System if the puncture site
is located in the superficial femoral artery or the profunda
femoris artery, since such puncture sites may result in a
pseudoaneurysm, intimal dissection, or an acute vessel
closure (thrombosis of small artery lumen) . Perform a femoral
angiogram to verify the location of the puncture site .
PrecAutIons
1 . The Prostar XL PVS System is provided sterile and non-
pyrogenic in unopened undamaged packages . Products
are sterilized with ethylene oxide and intended for single
use only . Do not resterilize . Store in a cool, dry place .
2 . Prior to use, inspect the Prostar XL PVS System to
ensure that the sterile packaging has not been damaged
during shipment . Examine all components prior to use
to verify proper function . Exercise care during device
handling to reduce the possibility of accidental device
breakage .
3 . As with all catheter-based procedures, infection is a
possibility . Observe sterile technique at all times when
using the Prostar XL PVS System . Employ appropriate
groin management, as per hospital protocol, post
procedure and post hospital discharge to prevent
infection .
4 . Use a single wall puncture technique . Do not puncture
the posterior wall of the artery . Avoid posterior wall
suture placement .
5 . Do not insert the Prostar XL PVS device into the femoral
artery at an angle greater than 45 degrees to the
longitudinal plane of the artery .
6 . An experienced operator should use accepted surgical
technique as warranted by surgical circumstances to
provide adequate knot security .
7 . There are no reaccess restrictions if previous arteriotomy
repairs were achieved with an Abbott Vascular Suture
Mediated Device .
8 . Do not advance or withdraw the Prostar XL
device against resistance until the cause of that
resistance has been determined (see Prostar XL
Device Placement section) . excessive force used to
advance or torque the Prostar XL PVs device should
be avoided, as this may lead to significant vessel
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