- 3 -
controller in the sterile field. The Azur Detachment Controller is
packaged separately as a sterile device.
Do not use any power
source other than the Azur Detachment Controller to detach
the coil. The Azur Detachment Controller is intended to be
used on one patient. Do not attempt to re-sterilize or
otherwise re-use the Azur Detachment Controller.
14. Prior to using the device, remove the proximal end of the delivery
pusher from the packaging hoop. Use care to avoid
contaminating this end of the delivery pusher with foreign
substances such as blood or contrast. Firmly insert the proximal
end of the delivery pusher into the funnel section of the Azur
Detachment Controller. See Figure 2.
Do not push the
detachment button at this time.
15. 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.
16. 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
17. Slowly advance the coil implant 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.
INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM
18. Open the RHV on the microcatheter 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
microcatheter 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 microcatheter. Use caution to
avoid catching the coil on the junction between the introducer
sheath and the hub of the microcatheter.
22. Push the Azur system through the microcatheter 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.
23. At this time, fluoroscopic guidance should be initiated. Depending
on length of microcatheter used, fluoroscopy initiation may be
delayed to minimize exposure.
24. Under fluoroscopic guidance, slowly advance the coil out the tip of
the microcatheter. 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.
25. Advance the coil into the desired site until the radiopaque marker
on the delivery pusher is aligned or slightly distal of microcatheter
distal tip RO marker, positioning the detachment zone just outside
the microcatheter tip. See Figure 4.
26. Tighten the RHV to prevent movement of the coil.
27. 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 microcatheter to move during
coil delivery. Catheter tip movement could cause the aneurysm
or vessel to perforate.
Figure 4
– Position of Marker Bands for Detachment
To minimize the potential risk of aneurysm or vessel perforation
DO NOT
advance the distal end of the delivery system past the
distal tip of the microcatheter.
DETACHMENT OF THE COIL
28. 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.
29. 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.
30. 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.
31. 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.
32. 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.
33. Verify the coil position before pushing the detachment button.
34. Push the detachment button. When the button is pushed, an
audible tone will sound and the light will flash green.
35. 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
