Terumo Angio-Seal VIP Mode D'emploi page 5

Figure 9 (Correct)
Resistance is felt as the
carrier tube is withdrawn.
5. Maintain grip on the insertion sheath and pull the
device handle straight back into the full rear locked
position (Figure 10). Resistance will be felt as the
device handle and sleeve snap lock. The device
sleeve colored bands should now be completely
visible.
NOTE: If the device sleeve separates from the
sheath while attempting full rear lock positioning,
do not push the Angio-Seal™ device forward to
reattach the sheath cap. Complete sealing of the
puncture following instructions in C-1.
Figure 10
Colored Band
6. Incorrect Indicator Alignment
The distal end of device cap completely covers
the colored indicator band on the device sleeve
(Figure 11). If the anchor catches prematurely as
in Figure 11, advance the device into the insertion
sheath again. It may be necessary to push the device
cap back into the rear holding position in order to get
full extension of the anchor from the sheath. Then
withdraw the device until the anchor catches correctly.
Figure 11 (Incorrect)
Resistance is felt, premature
deployment anchor leg catches
sheath for oblique deployment
NOTE: Do not proceed until you are certain that
the anchor has been properly deployed (Figure 9).
If the anchor is improperly deployed, the Angio-
Seal device will not function.
C. Seal the Puncture
1. Once the anchor has been deployed correctly
(Figure 9), and the device cap has been locked into
the rear position (Figure 10), slowly and carefully
withdraw the device/sheath assembly along the angle
of the puncture tract to position the anchor against the
vessel wall (Figure 12).
NOTE: Do not re-insert the device. Re-insertion
of the device after partial deployment could cause
collagen to be deposited in the artery.
TPRARTMT600006632 A_AngioSeal VIP_OUS.indd 3
Figure 12
Tissue
Artery
2. When the insertion sheath clears the skin, a tamper
tube will appear (Figure 13). At this stage, grip the
tamper tube and gently advance the knot and collagen
while maintaining tension on the suture.
Figure 13
Continue withdrawing.
Collagen is deployed
and Tamper Tube
appears.
Tamper Tube
Collagen
Tissue
Artery
WARNING: Failure to maintain tension on the
suture while advancing the collagen could cause
the collagen to enter the artery.
3. Continue to withdraw the insertion sheath and device
until the clear stop on the suture appears (Figure 14).
Continue to pull until all of the suture has been
deployed. The suture will then lock within the device
cap where it is attached. Maintain tension on the
suture.
Figure 14
Continue withdrawing.
Clear Stop is exposed.
Clear Stop
Tamper Tube
Tissue
Artery
3
4. Continue to maintain tension on the suture while
continuing to advance the knot and collagen with
the tamper tube, following the puncture tract angle
(Figure 15). A complete seal is indicated when
resistance is felt and hemostasis is achieved. As a
guide, in most cases a black compaction marker will
be revealed. The essential indicators for a seal are
resistance, hemostasis, and in most cases a black
compaction marker is revealed.
Figure 15
Push
Tamper Tube
Tissue
Artery
Figure 16
Push
See Detail
Tamper Tube
Detail
Tissue
Artery
NOTE: The black compaction marker is usually
exposed. If not, repeat step C-4. Sufficient
resistance will indicate completion of sealing
and the black compaction marker will usually be
exposed (Figure 16).
NOTE: In some cases the compaction marker will
be fully exposed when resistance is felt. In such
a case the clinician should check for hemostasis
before completing the procedure.
NOTE: Once hemostasis is achieved, do not tamp
to intentionally go beyond the distal end of the
black compaction marker (as shown in Figure 17)
in order to prevent anchor deformation and/or
collagen tearing.
Marker exposed
at completion of
tamping
11/29/2018 10:43:25 AM