English - Johnson & Johnson Cordis ANGIOGUARD RX Mode D'emploi

. Specification 10093469 Rev: 2
. DCR: 11822652 Effective: 4/24/2009
. IFU for the ANGIOGUARD(tm) RX

English

STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic.
For one use only. Do not use if package is open or
damaged. Not for sale in the U.S.A.
I. Contents
The Cordis ANGIOGUARD
System consists of one (1) each: ANGIOGUARD RX Emboli
Capture Guidewire, deployment sheath, capture sheath,
torque device/locking device, filter basket introducer, and peel
away guidewire introducer. (See Figure 1.)
II. Storage
Store in a cool, dark, dry place.
III. Description
The ANGIOGUARD RX Emboli Capture Guidewire is a
steerable guidewire available in several filter basket diameters.
Guidewire length, diameter, distal tip configuration and
guidewire support are indicated on the product label. It is a
single use, disposable guidewire with the addition of a filter
basket at the distal end of the guidewire. The filter basket
is used for trapping emboli during coronary, carotid, and
peripheral procedures. It consists of a thin, porous membrane
supported by a fine metal skeleton. In the collapsed state, the
filter basket has a very low profile. The ANGIOGUARD RX
Emboli Capture Guidewire System is used in a standard
fashion to cross the lesion and support the placement of
devices such as angioplasty balloons and intravascular stents.
Once the guidewire is across the lesion, the filter basket is
expanded in an umbrella-like fashion in the vessel lumen.
During the coronary, carotid or peripheral procedure, as the
blood passes through the filter basket, emboli are collected. At
the completion of the procedure, the filter basket is collapsed,
capturing the emboli, so it can be removed through the
guiding catheter or interventional sheath Introducer and out
of the body. The ANGIOGUARD RX Emboli Capture Guidewire
System has two (2) exit markers located on the proximal
shaft of the deployment and capture sheaths. These markers,
located at 90 and 100 cm respectively, approximate the exit
of the guidewire distal tip from the guiding catheter or the
interventional sheath.
IV. Indications
The ANGIOGUARD RX Emboli Capture Guidewire System is
intended for coronary, carotid, and peripheral uses to facilitate
the placement of diagnostic and interventional devices, and
capture emboli, thereby reducing the risk of embolization,
during procedures.
V. Contraindications
The ANGIOGUARD RX Emboli Capture Guidewire System is
contraindicated for use in conjunction with devices to treat
intracranial lesions. The ANGIOGUARD RX Emboli Capture
Guidewire System is contraindicated for use in chronic total
occlusions.
VI. Warnings
• Do not use the device if there are abnormalities in the
product or in the sterile barrier (e.g. broken seal, torn or
breached barrier).
• This device is intended for one time use only. Do not
resterilize and/or reuse. Structural integrity and/or function
may be impaired through reuse or cleaning.
• Use the ANGIOGUARD RX Emboli Capture Guidewire
System prior to the "Use By" date specified on the package.
• Observe all ANGIOGUARD RX Emboli Capture Guidewire
System movement in the vessels using fluoroscopic
guidance.
• Before the guidewire is moved, the tip should be visible
using fluoroscopy. Do not torque a guidewire without
observing corresponding movement of the tip; otherwise
vessel trauma could occur.
4
®
RX Emboli Capture Guidewire
IFU_10093632.2_pdf.pdf (4 file(s) total).
• If the wire tip becomes entrapped within the vasculature,
DO NOT TORQUE THE GUIDEWIRE.
• Torquing a guidewire against resistance may cause
guidewire damage and/or guidewire tip separation.
Always advance or withdraw the guidewire slowly. Never
push, auger, withdraw or torque a guidewire, which meets
resistance. Resistance may be felt and/or observed using
fluoroscopy by noting any buckling of the guidewire tip.
Determine the cause of resistance using fluoroscopy and
take the necessary remedial action.
• Perform all exchanges slowly to prevent air from entering
the catheter system or trauma.
• When introducing the guidewire, confirm that the
guiding catheter or interventional sheath Introducer tip
is free within the vessel lumen and not against the vessel
wall. Failure to do so may result in vessel trauma upon
guidewire exit from the device tip. Use the radiopaque
marker of the interventional device (guiding catheter or
sheath) to confirm position.
• Maintain an ACT of > 300 seconds during the time the
ANGIOGUARD RX Emboli Capture Guidewire filter is
deployed.
• Animal studies demonstrated the patency of this device
in vivo for up to 60 minutes.
VII. Precautions
• If distal perfusion of dye is significantly reduced or
no dye is perfusing past the distal marker band, the
ANGIOGUARD RX Emboli Capture Guidewire filter may
have reached its maximum capacity to contain emboli.
Remove and replace with a new ANGIOGUARD RX Emboli
Capture Guidewire System per section XIII.
• Do not attempt to close the filter basket with the
deployment sheath. The ANGIOGUARD RX Emboli
Capture Guidewire should only be removed using the
capture sheath.
• Care during diagnostic or interventional device exchanges
must be practiced to minimize movement of the guidewire
filter basket.
• Guidewires are delicate instruments and should be
handled carefully. Prior to use and when possible during
the procedure, inspect the guidewire carefully for coil
separation, bends, kinks, or damage of the filter basket
assembly. Figures 1 and 2 are used for reference only to
show coil dispenser, torque device, filter basket introducer,
emboli capture guidewire and basket, deployment sheath,
capture sheath, and flushing Luer hub.
Figure 1
coil
dispenser
approximate location
of hub (green)
torque
device
deployment sheath
(black)
deployment
peel
sheath
away
(yellow)
guidewire
introducer
emboli
capture
guidewire
and
basket
filter
basket
introducer
anti-migration
(clear)
clip
.