Johnson & Johnson Cordis ANGIOGUARD RX Mode D'emploi page 7

. Specification 10093469 Rev: 2
. DCR: 11822652 Effective: 4/24/2009
. IFU for the ANGIOGUARD(tm) RX
Figure 4
XI. Label Designation
Interventional .014" (0.36 mm) compatible devices mean:
• Angioplasty balloons
• Intravascular stents
XII. How to Detect if the ANGIOGUARD
Capture Guidewire Is Full
1. Once the ANGIOGUARD RX Emboli Capture Guidewire
is deployed in the vessel, it may capture emboli
during the entire time of the interventional procedure.
Therefore, it is recommended to check the status of the
ANGIOGUARD RX Emboli Capture Guidewire at regular
intervals during the intervention.
2.
Using fluoroscopy, perform a distal dye injection through
the guiding catheter or interventional sheath Introducer
and observe the flow of dye distal to the filter basket or
distal marker on the guidewire.
3. If the distal perfusion of dye is significantly reduced or
no dye is perfusing past the filter basket or guidewire
distal marker band, the ANGIOGUARD RX Emboli
Capture Guidewire may have reached its capacity to
contain emboli. If there is a severe reduction in distal
dye perfusion, it is recommended to exchange the
ANGIOGUARD RX Emboli Capture Guidewire for a new
one.
XIII. How to Exchange a Full ANGIOGUARD RX Emboli
Capture Guidewire
Caution: The ANGIOGUARD RX Emboli Capture
Guidewire should only be removed using the capture
sheath and should be removed through the guiding
catheter or interventional sheath Introducer ONLY. See
Section X, steps 14 & 15 for proper filter basket capture
and system removal.
IFU_10093632.2_pdf.pdf (4 file(s) total).
To exchange an ANGIOGUARD RX Emboli Capture Guidewire
System that has captured its capacity of emboli:
1.
2.
3.
4.
5.
6.
DISCLAIMER OF WARRANTY AND LIMITATION OF
REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY,
®
RX Emboli
INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ON THE CORDIS
PRODUCT(S) DESCRIBED IN THIS PUBLICATION.
UNDER NO CIRCUMSTANCES SHALL CORDIS
BE LIABLE FOR ANY DIRECT, INCIDENTAL, OR
CONSEQUENTIAL DAMAGES OTHER THAN AS
EXPRESSLY PROVIDED BY SPECIFIC LAW. NO
PERSON HAS THE AUTHORITY TO BIND CORDIS TO
ANY REPRESENTATION OR WARRANTY EXCEPT AS
SPECIFICALLY SET FORTH HEREIN.
Descriptions or specifications in Cordis printed
matter, including this publication, are meant solely
to generally describe the product at the time of
manufacture and do not constitute any express
warranties.
Cordis Corporation will not be responsible for
any direct, incidental, or consequential damages
resulting from reuse of the product.
Protected under one or more of the following U.S. Patents:
6,391,044; 6,428,559; 6,485,501; 6,540,768, and other U.S. and
foreign patents pending.
Remove all interventional devices from the
ANGIOGUARD RX Emboli Capture Guidewire.
Prep the capture sheath as outlined in the Preparations
for Use section, step 14 of section IX.
Load the capture sheath over the proximal end of the
ANGIOGUARD RX Emboli Capture Guidewire. Grasp the
guidewire proximally as it exits the RX port and advance
the capture sheath through the open hemostasis valve.
Continue to advance the capture sheath until the distal
capture sheath marker band is adjacent to the proximal
filter basket marker band. This collapses the filter basket.
Using fluoroscopy, confirm filter basket closure by
ensuring reduction of diameter of the radiopaque strut
marker bands.
Note: The emboli that have been captured may not
allow the ANGIOGUARD RX Emboli Capture Guidewire
to reach its initial low profile.
Open the hemostasis valve to allow the
ANGIOGUARD RX Emboli Capture Guidewire free
movement and reduce the likelihood of damage during
removal.
Remove the device by simultaneously pulling the
guidewire and capture sheath through the guiding
catheter or interventional sheath introducer, and out
of the hemostasis valve as a single unit. Care should
be taken when pulling the basket through the open
hemostasis valve, to avoid potential release of captured
emboli.
Resume the interventional procedure per Preparations
for Use, Section IX, steps 1 through 14, and Directions for
Use, Section X, steps 1 through 15.
.
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