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English
Perclose ProGlide 6F Suture-Mediated Closure (SMC)
System
INSTRUCTIONS FOR USE
Table of Contents
1.0 CAUTION
2.0
DEVICE DESCRIPTION
Figure 1: Perclose ProGlide Suture-Mediated Closure System
3.0
HOW SUPPLIED
4.0 INDICATIONS
5.0 CONTRAINDICATIONS
6.0 WARNINGS
7.0 PRECAUTIONS
8.0
SPECIAL PATIENT POPULATIONS
9.0
POTENTIAL ADVERSE EVENTS
10.0
THE PERCLOSE PROGLIDE SMC SYSTEM CLINICAL PROCEDURE
10.1 Examination and Selection of Products
10.2 Arterial Site and Puncture Considerations
10.3 SMC Device Placement 5F–8F Sheath, including Optional
Pre-Close and Maintaining Wire Access Techniques
10.3.1 Optional: Maintaining Wire Access During Knot
Advancement (Closing over the wire)
10.3.2 Optional: Pre-Close Technique
10.4 SMC Device Placement 8.5F–21F Sheath, Utilizing
Pre-Close and Maintaining Wire Access Techniques
10.5 Suture Breakage
10.6 Post-Procedure Patient Management
10.7 Recommendation for Patient Ambulation and Discharge
11.0
PRODUCT INFORMATION DISCLOSURE
12.0
PATENTS AND TRADEMARKS
TO ENSURE PROPER DEPLOYMENT AND USE OF THIS DEVICE AND TO
PREVENT INJURY TO PATIENTS, READ ALL INFORMATION CONTAINED IN
THESE INSTRUCTIONS FOR USE.
1.0 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 / or interventional 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.
2.0
DEVICE DESCRIPTION
The Perclose ProGlide Suture-Mediated Closure (SMC) System is designed
to deliver single monofilament polypropylene suture to close femoral artery
puncture sites following diagnostic or interventional catheterization procedures.
This Perclose ProGlide SMC device is composed of a plunger, handle, guide,
and sheath. The Perclose ProGlide tracks over a standard 0.038” (0.97 mm)
(or smaller) guide wire. A hemostasis valve restricts the blood flow through
the sheath with or without the guide wire in place. The guide houses the
needles, and the foot, and precisely controls the placement of these needles
around the puncture site. The handle is used to stabilize the device during
use. The plunger advances the needles and is used to retrieve the suture.
A marker lumen is contained within the guide, with the intraluminal port of
the lumen positioned at the distal end of the guide. Proximally, the marker
lumen exits from the body of the device. The marker lumen allows a pathway
for back-bleeding (obtaining mark) from the femoral artery to ensure proper
device positioning.
Knot pusher accessory (Perclose Suture Trimmer) is included, and is designed
to position the tied suture knot to the top of the arteriotomy. The Perclose
Suture Trimmer is also designed to trim the trailing limbs of suture.
The Perclose ProGlide 6F SMC System is designed for use in 5F to 21F
access sites.
The Perclose ProGlide SMC System is depicted in Figure 1.
Figure 1: Perclose ProGlide Suture-Mediated Closure System
3.0
HOW SUPPLIED
The Perclose ProGlide SMC device and accessories are provided sterile and
non-pyrogenic in unopened, undamaged packages. Products are sterilized
with ethylene oxide and intended for single use only. This single use device
cannot be reused on another patient, as it is not designed to perform as
intended after the first usage. Changes in mechanical, physical, and / or
chemical characteristics introduced under conditions of repeated use,
cleaning, and / or resterilization may compromise the integrity of the design
and / or materials, leading to contamination due to narrow gaps and / or
spaces and diminished safety and / or performance of the device. Absence
of original labeling may lead to misuse and eliminate traceability. Absence of
original packaging may lead to device damage, loss of sterility, and risk of
injury to the patient and / or user. Do not resterilize. Store in a cool, dry place.
Perclose ProGlide 6F SMC System includes:
One (1) Perclose ProGlide 6F SMC device
One (1) Perclose Suture Trimmer
4.0 INDICATIONS
The Perclose ProGlide SMC System is indicated for the percutaneous delivery
of suture for closing the common femoral artery access site of patients who
have undergone diagnostic or interventional catheterization procedures using
5F to 21F sheaths. For sheath sizes greater than 8F, at least two devices and
the pre-close technique are required.
5.0 CONTRAINDICATIONS
There are no known contraindications to the use of this device. Attention is
drawn to sections 6.0 WARNINGS and 7.0 PRECAUTIONS.
6.0 WARNINGS
Do not use the Perclose ProGlide SMC 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 Perclose ProGlide SMC device and
accessories are intended for single use only.
Do not use the Perclose ProGlide SMC 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 Perclose ProGlide SMC 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.
NOTE:
This may
require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO)
angiogram to adequately visualize where the sheath enters the femoral artery.
Do not use the Perclose ProGlide SMC System if the puncture is through the
posterior wall or if there are multiple punctures, since such punctures may
result in a hematoma or retroperitoneal bleed.
Do not use the Perclose ProGlide SMC System if the puncture site is
located in the superficial femoral artery or the profunda femoris artery, or
the bifurcation of these vessels, 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.
NOTE:
This may require both a Right Anterior Oblique (RAO)
and Left Anterior Oblique (LAO) angiogram to adequately visualize where the
sheath enters the femoral artery.
7.0 PRECAUTIONS
•
The Perclose ProGlide SMC System is provided sterile and non-pyrogenic
in unopened undamaged packages.
•
Prior to use, inspect the Perclose ProGlide SMC 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.
•
As with all catheter-based procedures, infection is a possibility. Observe
sterile technique at all times when using the Perclose ProGlide SMC
System. Employ appropriate groin management, as per hospital protocol,
post procedure and post hospital discharge to prevent infection.
•
Use a single wall puncture technique. Do not puncture the posterior wall
of the artery.
•
Do not insert the Perclose ProGlide SMC device into the femoral artery at
an angle greater than 45 degrees.
•
There are no reaccess restrictions if previous arteriotomy repairs were
achieved with Abbott Vascular SMC devices.
•
If significant blood flow is present around the Perclose ProGlide SMC
device, do not deploy needles. Remove the Perclose ProGlide SMC
device over a 0.038” (0.97 mm) (or smaller) guide wire and insert an
appropriately sized introducer sheath.
•
When pushing the plunger assembly to advance the needles, stabilize
the device to ensure the device does not twist or move forward during
deployment. Twisting the device could lead to needle deflection resulting
in a cuff miss. Do not use excessive force or repeatedly push the
plunger assembly. Excessive force on the plunger during deployment
could potentially cause breakage of the device, which may necessitate
intervention and / or surgical removal of the device and vessel repair.
•
Do not apply excessive force to the lever when returning the foot to its original
position
(marked #4)
down to the body of the device. Do not attempt to remove
the device without closing the lever. Excessive force on the lever of the device or
attempting to remove the device without closing the lever could cause breakage
of the device and / or lead to vessel trauma, which may necessitate intervention
and / or surgical removal of the device and vessel repair.
•
Do not advance or withdraw the Perclose ProGlide SMC device against
resistance until the cause of that resistance has been determined
(see section 10.3 SMC DEVICE PLACEMENT).
Excessive force used
to advance or torque the Perclose ProGlide SMC device should be
avoided, as this may lead to significant vessel damage and / or
breakage of the device, which may necessitate intervention and / or
surgical removal of the device and vessel repair.
•
If excessive resistance in advancing the Perclose ProGlide SMC device is
encountered, withdraw the device over a 0.038” (0.97 mm) (or smaller)
guide wire and reinsert the introducer sheath or use manual compression.
•
Remove the Perclose ProGlide 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.
A. Perclose ProGlide device
B. Perclose Suture Trimmer
RELEASED
RELEASED
