10
7. Using your thumb as a fulcrum on the handle, gently disengage the needles
by pulling the plunger assembly back
(in the direction marked #3)
and
completely remove the plunger and needles from the body of the device. One
suture limb will be attached to the anterior needle. The posterior needle will be
free of suture. Pull back on the plunger until the suture is taut, which confirms
that the suture has been fully retracted from the body of the device.
8. Do not attempt to redeploy the needles if the suture limb is not attached to the
anterior needle. Reinsert the guide wire, and remove the device over the wire.
Insert a new Perclose ProGlide SMC device to complete the procedure.
9. Use the QuickCut suture-trimming mechanism located on the handle to cut
the suture from the anterior needle distal of the link. Use of a new, sterile
scalpel or scissors is optional.
10. Relax the device and then return the foot to its original position by pushing the
lever
(marked #4)
on top of the device, down to its original position. Do not
attempt to remove the device without closing the lever.
11. Withdraw the Perclose ProGlide SMC device until the guide wire port exits
the skin line.
12. Slightly rotate the device until you can see the two suture limbs in the bend of
the distal guide. Grasp the sutures adjacent to the sheath. While holding the
two suture limbs
together
, gently pull both suture ends through the distal end
of the proximal guide.
13.
Immediately
place a shodded hemostat or clamp to hold the two suture
limbs together at the distal end of the non-rail suture limb (shortest limb with
white tip). To prevent knot advancement or locking of the knot, care must be
taken not to pull on the individual suture until the clamp is securely holding
the two suture limbs together.
14. Gently pull on the clamp until the suture is taut to
remove any suture
slack from the tissue tract.
Place the clamped suture on the
right side
of the patient under a sterile towel. It is important to identify which suture
is deployed first as this is the knot that needs to be advanced first at the
end of the procedure.
NOTE:
The monofilament suture can be damaged by
opening and closing the clamp. If you want to attach the suture to the drape,
it is recommended that you use a second clamp with the tip placed through
the handle of the first clamp and attach the second clamp to the drape. It is
important to remember this suture was placed first when suture tying occurs
at the end of the procedure.
15. Reinsert the guide wire. There should be sufficient guide wire inside the
vessel and exposed out of the guide wire exit port for device exchange.
16. Remove the Perclose ProGlide SMC device, while holding compression above
the puncture site and maintaining adequate length of guide wire inside the
artery. This allows placement of another Perclose ProGlide SMC device.
17. Repeat steps 2
–
13 with the second Perclose ProGlide device.
NOTE:
In
step 4, the second device should be rotated approximately 30 degrees
towards the patient’s left side (approximately 2 o’clock).
18. After removing any excess suture slack from the tissue track, place the
clamped suture for the second device on the left side of the patient under
a sterile towel. It is important to identify which suture was placed first and
which suture was placed second. At the completion of the procedure, the
suture knots will be advanced in the order they were placed. The knot from
the first device placed on the right side (10 o’clock) of the patient would be
advanced, followed by the knot from the second device placed on the left side
(2 o’clock) of the patient.
19.
Knot advancement will be placed on hold at this point and the sutures set
aside under sterile towels until the operator proceeds with the procedure.
20. When utilizing a pre-close technique, the Perclose ProGlide SMC device is
exchanged for an appropriately sized introducer sheath.
21. After completing the procedure, a hydrophilic or general purpose guide wire
should be advanced into the artery. Maintain adequate length of guide wire in
both the vessel and exposed out the guide wire exit port to ensure guide wire
access is maintained until hemostasis is achieved.
22. Heavily irrigate the secured Perclose ProGlide sutures with heparinized saline
to remove any dry blood.
23. Remove the clamp from the first suture (patient right side / 10 o’clock). The
rail suture limb is blue and is the longer of the two suture limbs. This rail
suture limb will be used to advance the knot. The shorter, non-rail suture limb
is white tipped and will be used to lock the knot.
24. Wrap the rail suture limb securely around your left forefinger, low, close to
skin level, and hold the suture coaxial to the tissue tract.
While maintaining
guide wire access,
carefully remove the entire sheath system and
simultaneously pull the rail limb with slow, consistent increasing tension.
Avoid quick or jerking type movements with the suture limbs. Manual
pressure should be applied proximal to the puncture site for hemostasis, while
the sheath is removed and during initial suture advancement.
25.
Do NOT lock the knot at this point.
Due to the size of the arteriotomy, use of
Suture Trimmer (section 10.3, step 13) may be needed to approximate the
tissue edges. However,
Do NOT lock or excessively tighten the knot while
the guide wire is still in the vessel.
Again place the suture limbs on the right
side of the patient for easy identification as the first suture deployed.
26. Remove the clamp from the second suture (patient left side / 2 o’clock) and
advance the knot using the same technique and
maintaining guide wire
access.
Again, do NOT lock the knot.
Place the suture limbs on the left side
of the patient for easy identification as the second suture placed.
27. Assess for hemostasis. If brisk bleeding is observed, advance the first (patient
right side / 10 o’clock) suture again and then advance the second (patient left
side / 2 o’clock) suture again. Multiple knot advancements are common when
closing larger sheath sizes. However,
DO NOT lock or excessively tighten the
knot while the guide wire is still in the vessel. Until the wire is removed,
some bleeding will be visible, but it should not be pulsatile blood flow.
28. If acceptable hemostasis is not observed, additional Perclose ProGlide SMC
devices may be deployed at this point. Repeat steps 2
–
11 with the next
Perclose ProGlide device.
NOTE:
In step 4, the third device should not be
rotated. The device will be deployed in a straight crania / caudad position
(logo facing the ceiling / 12 o’clock). After deployment of this device, advance
the knot in the same fashion.
DO NOT lock the knot or excessively tighten
the knot while the guide wire remains in the vessel.
29. Assess the site for adequate hemostasis.
If bleeding is controlled, the
operator should then remove the guide wire.
With the rail suture limb
(longer, blue limb) securely wrapped around the left forefinger, again advance
the first suture (patient right side / 10 o’clock) and then place the Suture
Trimmer under the left thumb to assume a single-handed position and
complete knot advancement with slow, consistent increasing tension until the
suture is taut (guitar string tightness). With the Suture Trimmer in place and
the suture taut, tighten the knot by gently pulling the non-rail (shorter, white
tipped) suture limb keeping it coaxial to the tissue tract.
30.
Do NOT cut the suture.
Follow the same steps to advance the second suture
(patient left side / 2 o’clock), coaxial to the tissue tract and lock the knot
but
do NOT cut the suture.
If applicable, advance the additional sutures and
lock the knots in the order that they were placed (10 o’clock, 2 o’clock,
12 o’clock). Assess bleeding. If hemostasis is deemed adequate, cut the
suture tails below the surface of the skin using the Suture Trimmer
(section 10.3, step 13 B) or a new, sterile scalpel or scissors.
10.5
Suture Breakage
1. If suture breakage occurs before the knot is tightened, as a wire is still in
place, discard the suture material, and use another Perclose ProGlide SMC
device to complete the procedure.
2. If suture breakage occurs after a knot has been advanced and / or tightened,
and a wire is still in place, another Perclose ProGlide SMC device can be used
to complete the procedure or a sheath can be inserted. Care should be taken
to avoid excessive force if the reintroduction of another device or introducer
sheath is required. To avoid resistance, use an introducer sheath small
enough to be introduced without undue force.
3. In all cases, if another Perclose ProGlide SMC device or introducer sheath
cannot be inserted, use manual compression to obtain hemostasis.
4. To prevent suture breakage, always pull on the suture limbs with slow,
consistent increasing tension. Avoid quick or jerking type movements with
the suture limbs.
5. To prevent damage to the suture and subsequent suture breaks, the Suture
Trimmer and suture limbs should always remain coaxial to the tissue tract.
The Thumb Knob should be at 12 o’clock (facing the ceiling) and the
Suture Trimmer should not be rotated. When loading the suture into the
Suture Trimmer, keep the Thumb Knob retracted until the suture and Suture
Trimmer are coaxial, then release the Thumb Knob to capture the suture in
the Suture Gate.
10.6
Post-Procedure Patient Management
1. Apply an appropriate dressing to the access site.
2. Assess the access site as per hospital standard of care.
10.7
Recommendation for Patient Ambulation and Discharge
Patients who have undergone a diagnostic or interventional procedure using
5F
–
8F sheaths may be ambulated two hours after the Perclose ProGlide SMC
device procedures.
For patients who have undergone an interventional catheterization procedure
using 8.5F
–
21F sheaths, post-procedure ambulation and patient care is at the
discretion of the physician.
In determining whether to ambulate or discharge an individual patient, it
is important to consider all clinical factors including, but not limited to,
anticoagulation regimen, antiplatelet and thrombolytic agents administered,
oozing or bleeding from the access site, venous access site hemostasis,
the general cardiovascular condition of the patient, anesthetic levels, and the
overall clinical condition of the patient.
11.0
PRODUCT INFORMATION DISCLOSURE
Abbott Vascular Inc. has exercised reasonable care in the manufacturing of
this device. Abbott Vascular Inc. excludes all warranties, whether expressed
or implied, by operation of law or otherwise, including but not limited to, any
implied warranties of merchantability of fitness, since handling and storage
of this device, as well as factors relating to the patient, diagnosis, treatment,
surgical procedures, and other matters beyond the control of Abbott Vascular
Inc. directly affect this device and the results obtained from its use. Abbott
Vascular Inc. shall not be liable for any incidental or consequential loss, damage,
or expense, directly or indirectly arising from the use of this device. Abbott
Vascular Inc. neither assumes, nor authorizes any other person to assume for it,
any other or additional liability or responsibility in connection with this device.
12.0
PATENTS AND TRADEMARKS
This product and / or its use may be covered by one or more of the following
United States Patents: 6,136,010; 6,190,396; 6,358,258; 6,558,399;
6,730,102; 6,746,457; 6,964,668; 7,001,400; 7,029,487; 7,048,747;
7,094,246; 7,147,646 ; 7,201,762; 7,235,087; EP 721313; EP 1093346.
Other U.S. patents pending. Foreign patents issued and pending.
QuickCut, Perclose, and ProGlide are trademarks of the Abbott Group of
Companies.
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