Boston Scientific WATCHMAN 12F Instrucciones De Uso página 6

11. Using fluoro and TEE confirm position of Delivery System tip before deploying the
Device.
note: To inject contrast, flush catheter or measure power injector pressure while
inserting Delivery System into Access Sheath. Contrast syringe or manifold must be
attached to flush port of Delivery System. If using a power injector, the maximum
pressure should not exceed 100 psi.
12. If repositioning is required, unsnap and slowly remove Delivery System from
Access Sheath. If necessary reinsert pigtail catheter to reposition Access Sheath.
Reinsert Delivery System as described in Steps 9 and 10.
13. Deploy WATCHMAN™ Device by loosening valve on Delivery System and holding
deployment knob stationary while retracting Assembly to completely deploy Device.
Leave core wire attached.
14. Device release criteria:
A. position: Plane of maximum diameter is at or just distal to and spans entire LAA
Ostium (See Figure 5).
figure 5. watcHMan laa closure Device position and size
B. anchor: Gently pull back then release deployment knob to visualize movement of
Device and LAA together.
C. size (compression): Measure plane of maximum diameter of Device (See
Figure 5). Use Table 2 as a guide.
D. seal: Ensure all lobes are distal to Device and sealed.
table 2. watcHMan laa closure Device Diameter
Original Diameter
(mm)
21
24
27
30
33
15. Partial Device Recapture
note: Partially recapture and redeploy WATCHMAN Device if too distal to LAA
ostium
A. Advance tip of Access/Delivery System Assembly up to Device (do not unsnap).
Fix deployment knob position with right hand and gently advance Access/
Delivery System Assembly over shoulders of Device. Position right thumb against
Delivery System hub for stability. Resistance will be felt as Device shoulders
collapse. Continue to advance Assembly up to but not past fixation anchors.
When resistance is felt a second time (anchor contact), stop, tighten hemostasis
valve.
note: If Device is retrieved past fixation anchors, recapture fully and replace
Delivery System. Refer to Step 16. The WATCHMAN Device and Delivery System
are for single use only. Do not reuse or resterilize.
Black (K) ∆E ≤5.0
Deployed Diameter
(80-92% of original) (mm)
16.8-19.3
19.2-22.1
21.6-24.8
24.0-27.6
26.4 -30.4
6
B. Reposition Access Delivery/System Assembly proximally and re-deploy
by holding deployment knob and retracting Access Sheath until Device is
completely deployed. Leave core wire attached.
warnInG: Do not release the WATCHMAN Device from the core wire if the
Device does not meet release criteria (Step 14).
16. Full Device recapture.
note: Fully recapture the Device if too proximal or does not meet release criteria
A. Advance tip of Access/Delivery System Assembly up to face of Device (do not
unsnap).
B. Fix deployment knob with right hand and gently advance Access/Delivery System
Assembly over shoulders of Device. Position right thumb against Delivery System
for stability. Resistance will be felt as Device shoulders collapse. Continue to
advance Assembly until Device is completely collapsed and recaptured (past
anchors).
C. Withdraw Device until distal tines are proximal to marker band then tighten
hemostasis valve.
D. Unsnap Delivery System from Access Sheath while maintaining position. Slowly
remove Delivery System.
E. Insert pigtail catheter to reposition Access Sheath in LAA if necessary.
F. Repeat Steps 7-14 with new Delivery System.
17. WATCHMAN Device Release: Confirm proper position, anchor, size, and seal,
and then advance Assembly to face of Device. Rotate deployment knob counter
clockwise 3-5 full turns. Confirm core wire is disconnected.
18. Remove Access Sheath and Delivery System based on parameters for hemostasis.
19. Use standard of care for post procedure bleeding at access site.
20. Post Procedure Information
A. Post-procedure warfarin therapy is required in ALL patients receiving a Device
who are eligible for warfarin therapy or other equivalent oral anticoagulant per
institution's protocol. Patients should remain on 81-100 mg of aspirin and warfarin
for a minimum of 45 days post implant (INR 2.0-3.0). At 45 days post implant
perform Device assessment with TEE. Cessation of warfarin is at physician
discretion. Patients ceasing warfarin should begin clopidogrel 75mg daily and
increase aspirin dosage to 300-325mg daily for 6 months post-implant and remain
on aspirin 300- 325mg indefinitely. For patients contraindicated to anticoagulation
therapy, begin clopidogrel 75mg daily and aspirin 300-325mg daily for 6 months
post-implant and remain on aspirin 300-325mg indefinitely. A visual assessment
with TEE should be performed 45 days post implant to assess the device.
B. At 45 days assess WATCHMAN Device with TEE.
• Confirm absence of intra-cardiac thrombus.
• Perform color Doppler assessment to include the device/LAA border at the
following approximate TEE angles (0°, 45°, 90°and 135°). Measure any residual
jet around the device if necessary.
C. Prescribe appropriate endocarditis prophylaxis for 6 months following Device
implantation. The decision to continue endocarditis prophylaxis beyond 6 months
is at physician discretion.
warranty
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in
the design and manufacture of this instrument. this warranty is in lieu of and excludes
all other warranties not expressly set forth herein, whether express or implied by
operation of law or otherwise, including, but not limited to, any implied warranties
of merchantability or fitness for a particular purpose. Handling, storage, cleaning and
sterilization of this instrument as well as other factors relating to the patient, diagnosis,
treatment, surgical procedures and other matters beyond BSC's control directly affect
the instrument and the results obtained from its use. BSC's obligation under this warranty
is limited to the repair or replacement of this instrument and BSC shall not be liable for
any incidental or consequential loss, damage or expense directly or indirectly arising
from the use of this instrument. BSC neither assumes, nor authorizes any other person
to assume for it, any other or additional liability or responsibility in connection with this
instrument. bsc assumes no liability with respect to instruments reused, reprocessed
or resterilized and makes no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose, with respect to such instruments.