Johnson & Johnson Cordis ANGIOGUARD RX Mode D'emploi page 6

. Specification 10093469 Rev: 2
. DCR: 11822652 Effective: 4/24/2009
. IFU for the ANGIOGUARD(tm) RX
3.
To remove the peel away guidewire introducer, retract
the peel away guidewire introducer from the guiding
catheter or interventional sheath introducer. Snap off the
peel away guidewire introducer hub and peel away the
entire introducer shaft.
4. Advance the guidewire through the guiding catheter or
interventional sheath introducer until it is proximal to
the tip of the guiding catheter or interventional sheath.
5.
Tighten the hemostatic valve slightly to reduce the
flow of blood from around the guidewire. Ensure that
movement of the guidewire is still possible.
6.
Using fluoroscopy, advance the guidewire out of the
guiding catheter or interventional sheath introducer. Use
the torque device to steer the guidewire through the
anatomy and across the lesion.
Note: Allow sufficient space between the lesion and
filter basket to prevent interference with the distal tips
of all other diagnostic and interventional devices (i.e.
stent delivery systems, angioplasty balloons) to be used
throughout the procedure.
7. Position the ANGIOGUARD
Guidewire so both distal and proximal radiopaque
markers are distal to the lesion to be treated.
8.
After achieving the appropriate guidewire position in the
vessel, remove the torque device from the guidewire.
Note: Always maintain filter basket position during
deployment sheath removal.
Note: Never attempt to recapture the filter basket using
the deployment sheath. If repositioning of the device
is necessary, use the capture sheath and reposition as
described in this section, step 14.
9.
By sliding the deployment sheath proximally, deploy
the filter basket while maintaining the guidewire
position. Confirm the filter basket is fully deployed with
fluoroscopy then close the hemovalve.
10. Separate the deployment sheath hub from the guidewire
by grasping the guidewire proximally in one hand and
pulling the hub away from the wire with the thumb and
index finger of the other hand. While maintaining the
guidewire position, use the hub to peel the deployment
sheath up to the hemovalve. Referring to Figure 3, place
one hand over the hemovalve and grasp it with the
ring and little fingers. Open the hemovalve. Maintain
guidewire position by holding the guidewire between
the thumb and index finger of the same hand. With
the other hand, peel the deployment sheath from the
guidewire by pulling on the hub parallel to the axis of
the guidewire. Complete the peeling step by pulling on
the black deployment sheath. Peeling is complete within
a few centimeters of the black to yellow sheath color
change. Remove the remaining un-slit sheath using a
standard over-the-wire technique.
Figure 3
6
IFU_10093632.2_pdf.pdf (4 file(s) total).
®
RX Emboli Capture
11. The ANGIOGUARD RX Emboli Capture Guidewire is now
fully deployed within the vessel. Confirm full deployment
using fluoroscopy. The marker bands on the filter basket
struts should be fully opposed to the vessel wall.
12. Using fluoroscopy, inject dye to determine that there is
adequate flow distal to the filter basket (or distal band
of the guidewire) and that the guidewire remains in the
proper position.
Note: Allow sufficient space between the lesion and
filter basket to prevent interference with the distal tips
of all other diagnostic and interventional devices (i.e.
stent delivery systems, angioplasty balloons) to be used
throughout the procedure.
13. Once guidewire position is confirmed, any rapid
exchange .014" (0.36 mm) compatible interventional
device can be loaded onto the guidewire for treatment
of the lesion. Use the standard rapid exchange technique
while treating the lesion. Be careful not to move the filter
basket during exchanges.
Note: Never attempt to capture the filter basket with the
deployment sheath.
14. Once the lesion is treated and all of the interventional
or diagnostic devices have been removed, remove the
flushed capture sheath (per step 14 of section IX) from
the dispenser coil and thread over the proximal end
of the guidewire. Grasp the guidewire proximally as it
exits the RX port and push the capture sheath through
the open hemostasis valve. Collapse the filter basket by
advancing the capture sheath until the distal capture
sheath marker band is adjacent to the proximal filter
basket marker band. Using fluoroscopy, confirm filter
basket closure by ensuring reduction of diameter of the
radiopaque strut marker bands.
Note: Do not try removing the ANGIOGUARD RX
Emboli Capture Guidewire by only pulling on the capture
sheath. Refer to Figure 4.
Note: Never pull the ANGIOGUARD RX Emboli Capture
Guidewire into the guiding catheter or interventional
sheath Introducer if there is resistance. If resistance is
encountered, reposition the capture sheath to ensure
that the filter basket is properly seated into the capture
sheath. Using fluoroscopy, verify capture sheath position
by checking marker band alignment between the
capture sheath and the guidewire.
15. Remove the device by grasping the guidewire and
capture sheath together (refer to Figure 4) near the
hemovalve. Pull the system through the guiding catheter
or interventional sheath Introducer, and out of the
hemovalve as a single unit. Care should be taken when
pulling the basket through the open hemovalve, to avoid
potential release of captured emboli.
.