- 3 -
Detachment Controller. See Figure 2.
Do not push the
detachment button at this time.
14. Wait three seconds and observe the indicator light on the
detachment controller.
If the green light does not appear or if a red light appears,
replace the device.
If the light turns green, then turns off at any time during the
three-second observation, replace the device.
If the green light remains solid green for the entire three-
second observation, continue using the device.
15. Hold the device just distal to the shrink-lock and pull the shrink-
lock proximally to expose the tab on introducer sheath. See
Figure 3.
Figure 3 - Pull Shrink Lock Proximally
16. Slowly advance the coil out of the introducer sheath and inspect
the coil for any irregularities or damage.
If any damage to the
coil or delivery pusher is observed, DO NOT use the device.
17. With the distal end of the introducer sheath pointed downward,
gently retract the implant back completely into the introducer
sheath about 1 to 2 cm.
INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM
18. Open the RHV on the catheter just enough to accept the
introducer sheath of the Azur system.
19. Insert the introducer sheath of the Azur system through the RHV.
Flush the introducer until it is completely purged of air and saline
flush exits the proximal end.
20. Seat the distal tip of the introducer sheath at the distal end of the
catheter hub and close the RHV
lightly
around the introducer
sheath to secure the RHV to the introducer.
Do not over-tighten the RHV around the introducer sheath.
Excessive tightening could damage the device.
21. Push the coil into the lumen of the catheter. Use caution to avoid
catching the coil on the junction between the introducer sheath
and the hub of the catheter.
Initiate timing using a stopwatch
or timer at the moment the device enters the catheter.
Detachment must occur within the specified reposition time.
22. Push the Azur system through the catheter until the proximal end
of the delivery pusher meets the proximal end of the introducer
sheath. Loosen the RHV. Retract the introducer sheath just out
of the RHV. Close the RHV around the delivery pusher. Slide the
introducer sheath completely off of the delivery pusher. Use care
not to kink the delivery system. To prevent premature hydration
of the Azur system, ensure that there is flow from the saline flush.
23. Discard the introducer sheath. The Azur system cannot be re-
sheathed after introduction into the microcatheter.
24. At this time, fluoroscopic guidance should be initiated. Depending
on length of catheter used, fluoroscopy initiation may be delayed
to minimize exposure.
25. Under fluoroscopic guidance, slowly advance the coil out the tip of
the catheter. Continue to advance the coil into the lesion until
optimal deployment is achieved. Reposition if necessary. If the
coil size is not suitable, remove and replace with another device.
If undesirable movement of the coil is observed under fluoroscopy
following placement and prior to detachment, remove the coil and
replace with another more appropriately sized coil. Movement of
the coil may indicate that the coil could migrate once it is
detached.
DO NOT
rotate the delivery pusher during or after
delivery of the coil into the vasculature. Rotating the delivery
pusher may result in a stretched coil or premature detachment of
the coil from the delivery pusher, which could result in coil
migration. Angiographic assessment should also be performed
prior to detachment to ensure that the coil mass is not protruding
into undesired vasculature.
26. Complete the deployment and any repositioning so that the coil
will be detached within the reposition time specified in Table 1.
After the specified time, the swelling of the hydrophilic polymer
may prevent passage through the catheter and damage the coil.
If the coil cannot be properly positioned and detached within
the specified time, simultaneously remove the device and the
catheter
.
27. Advance the coil into the desired site until the radiopaque marker
on the delivery pusher is aligned or slightly distal of catheter distal
tip RO marker, positioning the detachment zone just outside the
catheter tip. See Figure 4.
28. Tighten the RHV to prevent movement of the coil.
29. Verify repeatedly that the distal shaft of the delivery pusher is not
under stress before coil detachment. Axial compression or
tension could cause the tip of the catheter to move during coil
delivery. Catheter tip movement could cause the aneurysm or
vessel to perforate.
Figure 4
– Position of Marker Bands for Detachment
DETACHMENT OF THE COIL
30. The Azur Detachment Controller is pre-loaded with battery power
and will activate when a delivery pusher is properly connected. It
is in a “power off” mode when no delivery pusher is attached. It is
not necessary to push the button on the side of the Azur
Detachment Controller to activate it.
31. Verify that the RHV is firmly locked around the delivery pusher
before attaching the Azur Detachment Controller to ensure that
the coil does not move during the connection process.
32. Although the delivery pusher’s gold connectors are designed to
be compatible with blood and contrast, every effort should be
made to keep the connectors free of these items. If there appears
to be blood or contrast on the connectors, wipe the connectors
with sterile water or saline solution before connecting to the Azur
Detachment Controller.
33. Connect the proximal end of the delivery pusher to the Azur
Detachment Controller by firmly inserting the proximal end of the
delivery pusher into the funnel section of the Azur Detachment
Controller. See Figure 2.
34. When the Azur Detachment Controller is properly connected to
the delivery pusher, a single audible tone will sound and the light
will turn green to signal that it is ready to detach the coil. If the
detachment button is not pushed within 30 seconds, the solid
green light will slowly flash green. Both flashing green and solid
green lights indicate that the device is ready to detach. If the
green light does not appear, check to ensure that the connection
has been made. If the connection is correct and no green light
appears, replace the Azur Detachment Controller.
35. Verify the coil position before pushing the detachment button.
36. Push the detachment button. When the button is pushed, an
audible tone will sound and the light will flash green.
37. At the end of the detachment cycle, three audible tones will sound
and the light will flash yellow three times. This indicates that the
detachment cycle is complete. If the coil does not detach during
the detachment cycle, leave the Azur Detachment Controller
Pull shrink-lock
proximally
Tab on introducer
sheath
