Johnson & Johnson Cordis ANGIOGUARD RX Mode D'emploi page 5

. Specification 10093469 Rev: 2
. DCR: 11822652 Effective: 4/24/2009
. IFU for the ANGIOGUARD(tm) RX
Figure 2
coil
dispenser
VIII. Potential Complications
Procedures requiring percutaneous guidewire introduction
should not be attempted by physicians unfamiliar with the
possible complications. Complications may occur at any time
during or after the procedure.
Possible complications include, but are not limited to, the
following:
Coronary Indication
Air embolism
Infection
Vessel dissection,
perforation, rupture,
or injury
Death
Acute myocardial
infarction
Unstable angina
Dysrhythmia,
including ventricular
fibrillation
Hypo/Hypertension
Vessel Spasm
Arteriovenous or
vessel fistula
Intravascular stent
migration
IX. Preparations for Use
Prior to the interventional procedure, all equipment and
packaging, including the ANGIOGUARD
Capture Guidewire System, should be inspected and
examined carefully for defects. Check guidewire, filter
basket, deployment sheath, capture sheath, and capture
sheath RX port region (approximately 30 cm from the distal
tip) for bends, kinks, or other damage. Do not use defective
equipment.
1.
The package contains two plastic coil dispensers. One
contains the guidewire with filter basket, filter basket
introducer, peel away guidewire Introducer, torque
device, and black/yellow deployment sheath. The second
contains the blue capture sheath, which will not be
needed until the filter basket is ready to be removed
from the vessel.
flushing
Luer hub
cap
(white)
capture
sheath
(blue)
capture
sheath hub
(black)
Carotid Indication Peripheral
indication
Air embolism Air embolism
Infection Infection
Vessel dissection, Vessel dissection,
perforation, rupture, perforation, rupture,
or injury or injury
Death Vessel spasm
Acute myocardial Arteriovenous or
infarction vessel fistula
Unstable angina Ischemia
Dysrhythmia, Intravascular stent
including ventricular migration
fibrillation
Hypo/Hypertension TIA
Vessel Spasm Stroke
Arteriovenous or
vessel fistula
Intravascular stent
migration
TIA
Stroke
®
RX Emboli
IFU_10093632.2_pdf.pdf (4 file(s) total).
2. During shipping the deployment sheath tip may
become disengaged from the filter basket introducer.
Verify deployment sheath tip is engaged. If not, engage
manually by inserting deployment sheath tip into filter
basket introducer.
3.
Fill a 10-ml Luer lock syringe with sterile saline and purge
all air from syringe.
4.
Attach syringe to Luer lock hub on the end of the filter
basket introducer.
5. Inject 10 ml of saline to purge all air from the
deployment sheath and filter basket (ensure distal tip of
the deployment sheath is engaged with the filter basket
introducer tip prior to purging the system). You may
see saline dripping along the length of the deployment
sheath. Flushing is complete when saline is seen within
coil dispenser at the green deployment sheath hub.
6.
Disconnect syringe.
7. Remove the two anti-migration clips closest to torque
device and pull to ensure torque device is securely
attached to guidewire.
8. Gripping the torque device in one hand and the coil
dispenser in the other, pull on the wire until the basket
is completely docked into the tip of the deployment
sheath. When completely docked, approximately half
the filter basket will still be visible out the end of the
deployment sheath.
9. Remove the last anti-migration clip.
10. Open the torque device.
11. Gripping the torque device in one hand and the
proximal end of the guidewire in the other, pull the wire
through the torque device until the proximal end of the
deployment sheath hub engages the torque nut.
12. Lock the torque device onto the guidewire; ensure the
deployment sheath hub remains engaged with the
torque nut. Pull the wire and deployment sheath out of
dispenser coil.
13. The deployment sheath is now prepped and ready for
use.
14. Capture sheath – After the interventional or diagnostic
procedure is completed, attach a 10-ml Luer lock
syringe to flushing Luer hub, prepared as described in
Preparations for Use, step 3. Flush with 10 ml of sterile
saline. The entire coil dispenser should be filled with
saline. Remove the syringe from the flushing Luer
hub. Do not remove the capture sheath from the coil
dispenser until required system retrieval.
Filter Basket Sizing Recommendation
Nominal Filter
Basket Size
4.0 mm
5.0 mm
6.0 mm
7.0 mm
8.0 mm
X. Directions for Use
1. Insert the peel away guidewire introducer into the
interventional sheath introducer or the hemostatic valve
of the Y connector attached to the guiding catheter.
Ensure the hemostatic valve is fully opened before
inserting the guidewire introducer.
2. Carefully insert the deployment sheath assembly
through the peel away guidewire introducer and into the
guiding catheter or the interventional sheath introducer.
An 8F (2.7 mm) (.088" minimum ID) guiding catheter
or a 6F (2.0 mm) interventional sheath Introducer is
recommended for ease of removal.
Recommended
Vessel Size
3.0 mm < Vessel < 3.5 mm
3.5 mm < Vessel < 4.5 mm
4.5 mm < Vessel < 5.5 mm
5.5 mm < Vessel < 6.5 mm
6.5 mm < Vessel < 7.5 mm
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