Merit Medical Safeguard 24cm IFU - Manual

24cm PRESSURE ASSISTED DEVICE
I N S T R U C T I O N S F O R U S E
Read instructions prior to use.
Product not made with natural rubber latex.
DEVICE DESCRIPTION
The SAFEGUARD 24cm is a single use disposable device. SAFEGUARD
has a clear medical grade polyurethane window and bladder, a clear
medical grade PVC flexible fill tube, and a pressure sensitive, self-
adhesive peel backing. A luer valve on the end of the fill tube enables
a syringe to be connected to inflate the central bladder with air to
provide pressure to the puncture site. The SAFEGUARD pressure
assisted device has a sterile dressing with a clear window that
facilitates visibility of the access site without removal or manipulation
of the device.
INDICATIONS
The indications for use for the SAFEGUARD 24cm pressure assisted
device are to assist in obtaining and maintaining hemostasis.
The device is also indicated in the reduction of active compression
time in femoral artery cannulation following diagnostic and interven-
tional procedures with an ACT of 140 seconds or less, using a 6 Fr. and
smaller sheath size.
CONTRAINDICATIONS
The adhesive portion of the SAFEGUARD device should not be used
over excoriated skin.
CAUTIONS
Px Only. Caution: Federal (U.S.A.) law restricts this device to sale by or
on the order of a physician.
CAUTION: With over-inflation i.e., above 40mL’s of air, the bulb
may begin to expand radially and could compromise the adhesive
properties of the device.
CAUTION: Under-inflation of device could compromise the ability of
the device to assist in obtaining and maintaining hemostasis.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or
death of the patient.
PRECAUTIONS
• Use proper aseptic techniques while handling product.
• Do not use if package is damaged
• Inspect device prior to use to verify that no damage has occurred
during shipping.
POTENTIAL ADVERSE EFFECTS
Possible adverse effects that may result from the use of this device:
• Hematoma
• Local bleeding
• Arterio-venous fistula or pseudoaneurysm
SAFETY AND EFFECTIVENESS RESULTS
A clinical trial was conducted to evaluate the safety and effectiveness
of the SAFEGUARD Manual Assist Technique (MAT) in reducing active
compression time compared to historical manual compression data.
(Reduced Vascular Complications After Percutaneous Coronary
Interventions with a Non-mechanical Suture Device: Results from the
Randomized RACE Study, Sanborn, TA)
SAFEGUARD MAT Manual Compression
N=100 Historical Control
N=85
Avg. AC/TTH Manual 7.7 ± 3.3 28
Compression (minutes)
Manual Compression
SAFEGUARD Historical
MAT N=101 Control N=85
Major Complications
Access site bleeding
requiring transfusion
0 0 0 0
Vascular repair or the need
for vascular repair (via
0 1 0 2
surgery, ultrasound-guided
intervention, transcatheter
embolization, or stent-graft)
Any new ipsilateral lower
extremity ischemia
0 0 0 0
Surgery for access site
related nerve injury
0 0 0 0
Access site-related infection
requiring IV antibiotics or
0 0 0 0
extending hospitalization
Minor Complications * *
Access site hematoma
>6 cm (after sheath pull)
1 1 - -
Bleeding requiring
> 30 minutes to
0 0 - -
re-establish hemostasis 0 0 - -
Non-treated
pseudoaneurysm
0 0 - -
Non-treated arteriovenous
(AV) fistula documented
0 0 - -
by ultrasound
Skin excoreation at site
of Safeguard after removal
0 0 - -
of dressing
Skin erythema 0 0 - -
Allergic reaction to adhesive 0 0 - -
Ipsilateral lower extremity
arterial emboli, transient loss
0 0 - -
of lower extremity pulse, or
deep vein thrombosis
Access site-related vessel
laceration
0 0 - -
Transient access-site related
nerve injury
0 0 - -
Access site wound dehiscence 0 0 - -
Localized access site infection
treated with intramuscular
0 0 - -
or oral antibiotics
*None Reported
There is no statistical difference in the rate of major complications
between the control group and the treated group.
Diag
nostic
In
ter
ven
tional
Diag
nostic
In
ter
ven
tional
PRE-HEMOSTASIS, or MANUAL ASSIST TECHNIQUE (MAT)
PLACEMENT OF SAFEGUARD
1. Before adhering SAFEGUARD to the
patient, be sure skin is clean and dry.
Determine the appropriate angle for
SAFEGUARD placement to provide easy
access to luer inflate/deflate port and to
allow for easy sheath removal.
Note: Placement may require adjustment
based on the patient’s anatomy, angle
of the puncture site, and the presence or
absence of a procedural sheath.
2. Consider the point of maximum pulse,
anatomy, angle of puncture and
direction of flow to determine the
appropriate SAFEGUARD position and
verify.
3. Pull the procedural sheath back
approximately 1” (2.5cm) so that when
SAFEGUARD is adhered to the skin the
sheath hub is outside the area of the
SAFEGUARD adhesive.
Note: It is recommended that you aspirate
the sheath prior to removal to prevent distal
embolization from residual clot in sheath.
4. Remove the adhesive backing and place
the bulb where you would position your
fingers to hold manual compression (for
example, in femoral artery procedures,
typically the point of maximum femoral
pulse). Make sure SAFEGUARD is com-
pletely adhered to the skin.
5. Attach and completely engage a
standard luer lock syringe to inflate the
desired volume a maximum volume
of 40mL’s of air into the bulb to apply
pressure on the arteriotomy site. Syringe
must be completely engaged in the
luer to inflate/deflate the bulb. Remove
syringe.
Note: Maintain pressure on the plunger
while detaching syringe from the SAFE-
GUARD valve. Observe that the desired
pressure is achieved and maintained.
6. Remove sheath, then immediately
apply manual compression directly over
inflated bulb.
7. Hold manual compression until hemo-
stasis has been achieved.*
• Slowly release manual compression.
• Check distal/proximal pulses to assure
flow is maintained.
• Confirm hemostasis by viewing the site
through the inflated bulb window.
* Recommendations (MAT only):
Diagnostic patients - minimum 5 minutes
Interventional patients - minimum 10 minutes
8. Per hospital protocol, periodically check the site through the bulb
window to confirm hemostasis and to manage the bulb volume
and resultant pressure as needed. Continue to check distal/
proximal blood flow to assure patency.
9. Deflate bulb every two hours to allow for capillary refill and to
assess the site. Re-inflate the bulb if necessary.
10. Deflate the bulb by attaching an appropriately sized luer lock sy-
ringe to the valve, engage the valve and slowly depress the bulb
allowing the syringe to fill with air. Alternatively, remove plunger
from the syringe, attach syringe and allow air to slowly release
while gently depressing the bulb.
Note: Do not draw negative pressure in the syringe, as this will create
a vacuum on the site.
11. Prior to discharge of the patient, remove SAFEGUARD and apply
sterile dressing per hospital protocol.
POST-HEMOSTASIS TECHNIQUE
1. When hemostasis at the access site has
been achieved, apply the SAFEGUARD
device with the access site visible under
the bulb window of the SAFEGUARD
device. Consider the point of maximum
pulse, anatomy, angle of puncture
and direction of flow to determine the
appropriate SAFEGUARD position and
verify.
Note: Before adhering SAFEGUARD to the
patient, be sure skin is clean and dry. Deter-
mine the appropriate angle for SAFEGUARD
placement to provide easy access to luer
inflate/deflate port.
2. Attach an appropriately sized standard
luer lock syringe to the valve of the
SAFEGUARD device.
Note: Syringe must be completely engaged
in the luer to inflate/deflate the bulb.
3. Inflate the bulb of the SAFEGUARD
device with air to the desired volume of
air (24cm maximum of 40mL’s) to apply
pressure on the arteriotomy site and re-
move the syringe. Check distal/proximal
pulses to assure flow is maintained.
Note: Maintain pressure on the plunger
while detaching syringe from the valve of
the SAFEGUARD device. Observe that the
desired volume is achieved and maintained.
4. Per hospital protocol, periodically check the site through the bulb
window to assure hemostasis is maintained and the bulb maintains
pressure.
5. Deflate bulb every two hours and assess the site. Re-inflate the bulb
if necessary.
6. Deflate the bulb by attaching an appropriately sized luer lock
syringe to the valve, engage the valve and slowly depress the bulb
allowing the syringe to fill with air. Alternatively, remove plunger
from the syringe, attach syringe and allow air to slowly release
while gently depressing the bulb.
Note: Do not draw negative pressure in the syringe, as this will create a
vacuum on the site.
7. Prior to discharge of the patient, remove the SAFEGUARD device
and apply sterile dressing per hospital protocol.
Maintain sterile field during application.
Keep away from sunlight
Do not Resterilize
Do not Reuse
Do not use if package is damaged
Catalog Number
Lot Number
Use By
Sterilized Using Gamma
Caution: Consult accompanying document
Manufacturer
Authorized Representative
Manufacturer: Merit Medical Systems, Inc.
1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A. 1-801-253-1600
U.S.A. Customer Service 1-800-356-3748
www.merit.com ID 010814 400373001/A