Boston Scientific WATCHMAN 12F Instrucciones De Uso página 5

2. Exchange crossing sheath with exchange length extra support 0.035" guidewire.
Position guidewire in left upper pulmonary vein (LUPV) or loop in left atrium.
3. Prepare WATCHMAN™ Access System.
A. Remove Access Sheath and Dilator under sterile conditions.
B. Inspect prior to use to ensure no damage.
note: Inspect sterile package and WATCHMAN Access System prior to use. If
sterile barrier has been compromised in any way, DO NOT USE.
C. Flush Access Sheath and Dilator with saline prior to use.
D. Insert Dilator into hemostasis valve of Access Sheath.
note: Audible snap upon connection of Dilator and hemostasis valve of Access
Sheath.
note: Do not tighten the hemostasis valve while the Dilator is inserted in the
WATCHMAN Access System. The Dilator by itself will occlude the lumen of the
WATCHMAN Access System creating hemostasis. Tightening the valve onto the
Dilator may damage the valve threads, which can lead to subsequent difficulty in
closing the valve and an incomplete seal, once the Dilator is removed.
4. Advance WATCHMAN Access System over guidewire into left atrium (LA). As
Access Sheath nears center of LA, hold Dilator and advance Access Sheath into
initial position in LA or ostium of LUPV.
note: Use caution when introducing WATCHMAN Access System to prevent
damage to cardiac structures.
5. Remove Dilator and guidewire, leaving Access Sheath. Allow back bleed to
minimize potential for introducing air before tightening valve. Flush with saline.
If continued back bleed is observed from the valve after the Dilator is removed
despite attempting to close it, loosen the valve cap (counter-clockwise rotation)
until the cap spins freely. Then re-attempt closure of the valve while exerting gentle
forward pressure on the valve cap during closure (clockwise rotation) to ensure
proper engagement of the valve thread. While these steps are being undertaken,
manual occlusion of the valve opening using a gloved finger is recommended to
minimize blood loss.
note: These steps may be repeated if necessary. However, if this does not mitigate
the blood leak, the user should remove and replace the WATCHMAN Access
Sheath before proceeding with the procedure.
6. Confirm LAA size and select appropriate WATCHMAN LAA Closure Device.
A. Using TEE, measure LAA ostium width and LAA length in 3-4 views (0°, 45°, 90°,
135°).
B. Choose a device based on maximum LAA ostium width recorded. Use Table 1 as
a guide.
note: LAA anatomy should accommodate a Device as described in Table 1.
table 1. watcHMan laa closure Device selection
Max LAA Ostium (mm)
17 – 19
20 – 22
23 – 25
26 – 28
29 – 31
note: Record multiple angles on cine with contrast prior to advancing Access
Sheath into LAA. Use fluoro guidance while advancing pigtail catheter, or Access
Sheath. Stop if resistance is felt.
C. Carefully advance pigtail catheter through Access Sheath into distal LAA under
fluoro guidance (Figure 3). Carefully advance Access Sheath over pigtail catheter
until Access Sheath marker band corresponding to Device size (see Figure 4) is
at or just distal to LAA ostium. Slowly remove pigtail catheter.
figure 3. watcHMan access sheath and pigtail catheter
figure 4: watcHMan access sheath Marker bands
7. Prepare WATCHMAN Delivery System
Device Diameter (mm)
21
24
27
30
33
8. Loosen proximal valve of Access Sheath allowing bleed back before inserting
9. To avoid introduction of air, slowly advance Delivery System into Access Sheath
10. On fluoro, align most distal marker band on Delivery System with most distal marker
5
A. Remove Delivery System under sterile conditions.
B. Inspect prior to use to ensure no damage to handle, catheter connections and
Device (through Delivery System).
note: If sterile barrier has been compromised in any way, or Delivery System
appears damaged DO NOT USE.
C. Confirm that the distal tip of the Device is aligned with marker band on Delivery
System.
caUtIon: Do not allow WATCHMAN Device to protrude to prevent damage to
Delivery Catheter.
D. Flush system with saline removing all air and maintaining fluid throughout
Delivery System. Open and flush proximal valve.
note: To avoid introducing air, apply pressurized saline bag to sideport of Access
Sheath, or submerge Access Sheath hub in saline. Saline may be dripped from
Delivery System during introduction into Access Sheath by injecting through
flush port.
Delivery System. Note: Hemostasis valve should spin freely (fully open).
note: Tightening the valve onto the WATCHMAN Delivery System may damage the
valve threads, which can lead to subsequent difficulty in closing the valve and an
incomplete seal, once the WATCHMAN Delivery System is removed.
under fluoro guidance.
note: Use caution when introducing Delivery System to prevent damage to cardiac
structures.
band on Access Sheath. Once bands are aligned, stabilize Delivery System, retract
Access Sheath and snap together as Access Sheath/Delivery System Assembly.
Distal
Marker
Band
Black (K) ∆E ≤5.0