Medtronic FiberNet Gebrauchsanweisung Seite 10

FiberNet_CH.fm 3/29/12 01:17 pm
8.46 x 11.02 inches (215.0 mm x 280.0 mm)
4. Advance the capture wire through the introducer and into the guiding
catheter/sheath until the black section is completely inside the guiding
catheter/sheath.
5. Loosen the adapter and peel the pre-slit introducer off the wire to
remove.
6. Steer the capture wire by applying torque to the wire. A standard wire
torque device may be used.
7. Advance the capture wire until the filter is distal to the target lesion(s)
and position as shown in Figure 1.
8. If the filter will not cross the lesion, balloon angioplasty with a small
diameter balloon is acceptable prior to placement.
Caution: The filter should not be within the lesion during the dilation.
Caution: If the wire kinks before deployment, remove the device and
replace with another system.
Caution: Leave the actuator cover closed until instructed to open.
9. Attach the actuator (Figure 2) to the capture wire's proximal end by
sliding the proximal wire end through the wire funnel until the wire will
no longer advance and is visible in the viewing window.
10. Fully open the actuator cover to lock the actuator onto the wire.
Figure 3 shows the actuator with cover open.
11. Under fluoroscopy, maintain the position of the capture wire and deploy
the filter by holding the actuator and turning the dial clockwise to the
deployed position. Once fully deployed, the dial will point to the filter up
position and the safety button will engage the dial.
Note: The radiopaque capture wire tip will slide proximally toward the
proximal marker band and the 2 inner markers will touch at the center
of the filter upon deployment (Figure 4).
12. Close the actuator cover to release the wire. Remove the actuator from
the wire.
13. If desired, filter deployment can be further verified by placing the
stainless steel hypotube transition area against the specified location
on the actuation template on the back of the actuator (Figure 5). The
filter will be fully deployed if the proximal end of the wire is within the
specified band on the actuation template.
Note: If unsure the FiberNet filter is deployed, retract the filter, remove
the device, and replace it with another system. To retract the filter slide
the proximal wire end through the wire funnel until the wire will no longer
advance and is visible in the viewing window. Open the actuator cover.
Turn the dial counter clockwise toward the filter down position until the
safety button engages the dial.
14. Inject contrast medium and verify that the filter is in the proper position.
Verify adequate flow through the filter.
Note: The filter can be retracted, repositioned, and redeployed if
necessary.
15. Use the capture wire as a standard guidewire to track compatible
interventional devices to target treatment area.
9.5 DURING THE PROCEDURE
1. Periodically inject contrast medium to visually verify that blood flow is
not obstructed.
Caution: If blood flow is slowed or stopped during the procedure the
filter may be aspirated to remove excess debris. However, at the
discretion of the operator, the procedure may be completed as normal
before final aspiration and filter retrieval.
2. Exercise caution when loading interventional devices onto the capture
wire to avoid kinking.
3. Complete the procedure, making sure the filter remains in the proper
position, distal to the lesion site.
9.6 RETRIEVAL OF THE CAPTURE WIRE
1. Taking care not to kink the capture wire, insert the wire's proximal end
into the loading tool's distal end that extends out the distal end of the
retrieval catheter.
2. Carefully advance the wire and loading tool out the side port of the
catheter.
3. Remove the loading tool.
4. Open the Tuohy Borst adapter and insert the catheter.
5. Advance the catheter tip until the distal marker band on the catheter tip
is aligned with the proximal filter marker.
6. Verify catheter tip placement using fluoroscopic imaging.
Note: If resistance is felt passing the catheter through the stent, pull
back on the catheter and torque the catheter ¼ turn. Continue to
advance the catheter to the proximal filter marker.
7. Attach the syringe to the extension tube assembly on the catheter.
8. Retract and lock the syringe in the fully extended position (30 mL).
9. Open the stopcock to begin first aspiration cycle.
Caution: If filter will not fully retract into the catheter, do not apply force.
Remove the partially retracted filter under aspiration.
Note: The catheter is designed to deliver an effective aspiration
vacuum for a minimum of 10 seconds. If blood is not filling the syringe
within 5 seconds, check the catheter tip placement, remove the
catheter and reposition if necessary. If no blood is aspirated after
repositioning the catheter, close the stopcock and remove the catheter.
Outside the patient, flush the catheter or use a new catheter. If
aspiration stops before the syringe has filled, close the stopcock and
remove the catheter. Outside the patient, flush the catheter or use a
new catheter.
Caution: Never flush the catheter while it is in the patient.
8 English Instructions for Use
0110105-00
Medtronic Confidential
10. Attach the actuator to the capture wire's proximal end by sliding the wire
end through the wire funnel until there is a hard stop and the wire is
visible in the window.
11. Fully open the actuator cover to lock wire in place.
12. Using fluoroscopic imaging, verify the distal marker band on the
catheter is aligned with the proximal filter marker and prepare to retract
the filter within the second aspiration cycle.
13. Open the stopcock to begin the second aspiration cycle.
14. Once aspirated fluid is visible in the syringe, under fluoroscopy retract
the filter by pressing the safety button down and turning the dial
counter-clockwise toward the filter down position until the safety button
engages the dial.
Note: The radiopaque capture wire tip will slide distally away from the
proximal marker band and the 2 inner markers will separate at the
center of the filter upon retraction.
Caution: To avoid damaging the filter integrity, do not use force when
retrieving the filter.
15. Under fluoroscopy, hold the catheter position with one hand and slowly
pull the capture wire, with the other hand, completely into the catheter.
Note: Slight resistance will be felt while the filter is entering the
catheter. The capture wire distal tip should be aligned or slightly
proximal to the catheter marker band.
16. With the capture wire inside the catheter, slowly and carefully remove
the entire system (as a unit) from the patient, ensuring that the filter
does not exit the catheter.
17. After use, this product may be a potential biohazard. Handle and
dispose of all such devices in accordance with accepted medical
practice and applicable local, regional, and national laws and
regulations.
10.0 DISCLAIMER OF WARRANTY
NOTE: ALTHOUGH THE MEDTRONIC FIBERNET EMBOLIC PROTECTION
DEVICE, HEREAFTER REFERRED TO AS "PRODUCT," HAS BEEN
MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS,
MEDTRONIC, INC., MEDTRONIC VASCULAR, INC., AND THEIR
AFFILIATES (COLLECTIVELY, "MEDTRONIC") HAVE NO CONTROL OVER
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC,
THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESSED AND
IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE
LIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR
ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED
BY ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT,
WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY,
CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY AUTHORITY
TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH
RESPECT TO THE PRODUCT.
The exclusions and limitations set out above are not intended to and should
not be construed so as to contravene mandatory provisions of applicable law.
If any part or term of this Disclaimer of Warranty is held to be illegal,
unenforceable, or in conflict with applicable law by a court of competent
jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty
shall not be affected.
CS0048