Cordis PRECISE PRO RX Gebrauchsanleitung Seite 9

PPE Specification
Labeling Specification
Precure Pro Rx OUS Carotid IFU
3. Introduction of Stent Delivery System
a. Flush the guidewire lumen of the stent delivery system with heparinized saline by
connecting a 5-cc syringe filled with heparinized saline solution to the stopcock attached
to the Y connection (9) on the Tuohy Borst valve (1) to expel air. Ensure that the Tuohy
Borst valve (1) is in the locked position to prevent premature stent deployment. Apply
positive pressure to the syringe until saline weeps from the guidewire exit port (16).
While covering the guidewire exit port (16) with thumb and forefinger, apply positive
pressure to the syringe until saline weeps from the catheter tip (4) and the space
between the outer sheath radiopaque marker (11) and the catheter tip (4). Continue to
flush to ensure all air is removed from the system, then close the stopcock attached to
the Y connection (9) on the Tuohy Borst valve (1).
b. Ensure that the Tuohy Borst valve connecting the inner shaft and outer sheath is locked
by rotating the proximal valve end in a clockwise direction to prevent premature stent
deployment.
Advance the PRECISE PRO RX System over the .014" (0.36 mm) ANGIOGUARD RX
c.
Emboli Capture Guidewire System until the guidewire exit port (16) is just outside the
accessory device's Tuohy Borst valve. Adjust the accessory device's Tuohy Borst valve to
maintain a snug seal about the PRECISE PRO RX System. Look for and confirm back flow
through the guidewire exit port (16) opening.
d. After confirming back flow, advance the PRECISE PRO RX System. Again adjust the
accessory device's Tuohy Borst valve to maintain a snug seal, now over the .038" (0.97
mm) proximal shaft (6A) and continue to advance the PRECISE PRO RX System to the
lesion site.
e. Prior to contrast injection, confirm again a snug seal between the .038" (0.97 mm)
proximal shaft (6A) of the PRECISE PRO RX System and the accessory device's Tuohy
Borst valve. FAILURE TO DO SO COULD RESULT IN AIR INTRODUCTION DURING
ASPIRATION, RESULTING FROM A POOR SEAL.
NOTE: If resistance is met during delivery system introduction, the system should be
withdrawn and another system should be used.
4. Slack Removal
a. Advance the stent delivery system past the lesion site.
b. Pull back the stent delivery system until the radiopaque inner shaft markers (leading and
trailing ends) move in position so that they are proximal and distal to the target lesion.
c. Ensure that the stent delivery system outside the patient remains flat and straight.
CAUTION: Slack in the catheter shaft either outside or inside the patient may result in
deploying the stent beyond the lesion site.
5. Stent deployment
NOTE: When ready to proceed with stent deployment, heparin may be administered per
standard hospital practice or as prescribed by a physician. Heparin may be continued
following stent deployment if so indicated by a physician or hospital protocol.
a. Verify that the delivery system's radiopaque inner shaft markers (leading and trailing
ends) are proximal and distal to the target lesion.
b. Unlock the Tuohy Borst valve connecting the inner shaft and outer sheath of the delivery
system.
c. Ensure that the access sheath or guiding catheter does not move during deployment.
d. Initiate stent deployment by retracting the outer sheath while holding the inner shaft
in a fixed position. Deployment is complete when the outer sheath marker passes the
proximal inner shaft stent marker.
NOTE: The mechanism for stent deployment is outer sheath retraction. Deployment is
completed by maintaining inner shaft position while retracting the outer sheath and
allowing the stent to expand (often referred to as the "pin-and-pull" method).
NOTE: When more than one stent is required to cover the lesion, the more distal stent
should be placed first. Efforts should be taken to minimize the stent overlap. In no
instance, should more than two (2) stents ever overlap.
6. Post-deployment Stent Dilatation
a. While using fluoroscopy, withdraw the entire delivery system as one unit, over the
guidewire and out of the body. Remove the delivery device from the guidewire.
NOTE: If any resistance is met during delivery system withdrawal, advance the outer
sheath until the outer sheath marker contacts the catheter tip and withdraw the system
as one unit. (Do not remove guidewire.)
b. Using fluoroscopy, visualize the stent to verify full deployment.
c. If incomplete expansion exists within the stent at any point along the lesion, post
deployment balloon dilatation (standard PTA technique) can be performed.
d. Select an appropriately sized PTA balloon catheter and dilate the lesion with
conventional technique. The inflation diameter of the PTA balloon catheter used for post
dilatation should approximate the diameter of the reference vessel. Remove the PTA
balloon catheter from the patient.
7. Post Stent Placement
a. A post stent angiogram should be obtained.
b. Remove the ANGIOGUARD RX Emboli Capture Guidewire System in accordance with
ANGIOGUARD RX Instructions for Use. Remove the sheath and establish hemostasis.
c. After use, all components used and packaging materials may be a potential biohazard.
Handle and dispose of in accordance with the accepted medical practice and with
applicable local, state and federal laws and regulations.
NOTE: Physician experience and discretion will determine the appropriate post
procedure drug regimen for each patient.
XV. Magnetic Resonance Imaging (MRI) Safety Information
A patient with the PRECISE stent may be safely scanned under the following conditions.
Failure to follow these conditions may result in injury to the patient.
Name/identification of device
Nominal values of static magnetic field
Tesla (T)
Maximum spatial field gradient (T/m)
and (Gauss/cm)
Radio Frequency (RF) excitation
RF transmit coil type
RF receive coil type
Maximum whole body Specific Absorption
Rate (SAR) (W/kg)
Limits on scan duration
Magnetic Resonance (MR) image artifact
Non-clinical testing has demonstrated that the PRECISE Stent is MR Conditional in single
and overlapped configuration up to a maximum of 60 mm as defined in ASTM F2503-13.
If information about a specific parameter is not included, there are no conditions associated
with that parameter.
XVI. How supplied
The Cordis PRECISE PRO RX Nitinol Stent System is supplied sterile(by ethylene oxide gas) and
is intended for ONE USE ONLY. Also, included in the packaging: One (1) stent implant card.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, 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 will not be responsible for any direct, incidental, or consequential damages
resulting from reuse of the product.
11060616 | Rev:13
Released: 26 Jan 2022
CO: 100553075
Release Level: 4. Production
Cordis PRECISE Stents
1.5 T and 3.0 T
40 T/m (4000 Gauss/cm)
Circularly polarized (CP)
Whole body transmit coil
Head RF transmit-receive coil
Any receive only coil may be used
2.0 W/kg
15 minutes of continuous RF (a sequence
or back to back series/scan without breaks)
followed by a wait time of 10 minutes if this
limit is reached
The presence of this implant produced an
image artifact of approximately 16 mm when
imaged with a gradient echo pulse sequence
and a 3.0 T MRI system
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