PD110323 Rev. A
3
MicroVention, Inc.
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 attached to the delivery pusher and attempt another
detachment cycle when the light turns green.
38.
The light will turn red after the number of detachment cycles specified on
the Azur Detachment Controller labeling. DO NOT use the Azur detachment
controller if the light is red. Discard the Azur Detachment Controller and replace
it with a new one when the light is red.
39.
Verify detachment of the coil by first loosening the RHV valve, then pulling back
slowly on the delivery system and verifying that there is no coil movement. If the
implant did not detach, do not attempt to detach it more than two additional
times. If it does not detach after the third attempt, remove the delivery system.
40.
After detachment has been confirmed, slowly retract and remove the delivery
pusher.
Advancing the delivery pusher once the coil has been detached
involves the risk of aneurysm or vessel rupture. Do NOT advance the
delivery pusher once the coil has been detached
.
41.
Verify the position of the coil angiographically through the guide catheter.
42.
Additional coils may be deployed into the lesion as described above. Prior to
removing the microcatheter from the treatment site, place an appropriately sized
guidewire completely through the microcatheter lumen to ensure that no part of
the last coil remains within the microcatheter.
The physician has the discretion to modify the coil deployment technique to
accommodate the complexity and variation in embolization procedures. Any technique
modifications must be consistent with the previously described procedures, warnings,
precautions and patient safety information.
SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER
• Output voltage: 8 ± 1 VDC
• Cleaning, preventative inspection, and maintenance: The Azur Detachment
Controller is a single use device, preloaded with battery power, and packaged
sterile. No cleaning, inspection, or maintenance is required. If the device does not
perform as described in the Detachment section of these Instructions, discard the
Azur Detachment Controller and replace it with a new unit.
• The Azur Detachment Controller is a single use device. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn, may result
in patient injury, illness, or death. Reuse, reprocessing, or resterilization may
also create a risk of contamination of the device and/or cause patient infection
or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to
injury, illness or death of the patient.
• Batteries are pre-loaded into the Azur Detachment Controllers. Do not attempt to
remove or replace the batteries prior to use.
• After use, dispose of the Azur Detachment Controller in a manner consistent with
local regulations.
PACKAGING AND STORAGE
The Azur system is placed inside a protective, plastic dispenser hoop and packaged
in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile
unless the package is opened, damaged, or the expiration date has passed. Store at a
controlled room temperature in a dry place.
The Azur Detachment Controller is packaged separately in a protective pouch and
carton. The Azur Detachment Controller has been sterilized; it will remain sterile
unless the pouch is opened, damaged, or the expiration date has passed. Store at a
controlled room temperature in a dry place.
SHELF LIFE
See the product label for the device shelf life. Do not use the device beyond the
labeled shelf life.
MR INFORMATION
The coil implant has been determined to be
MR conditional
according to the
terminology specified in the American Society for Testing and Materials (ASTM)
International, Designation: F2503-08.
Non-clinical testing demonstrated that the coil implant is
MR conditional
. A patient
can be scanned safely, immediately after placement under the following conditions:
• Static magnetic field of 3 Tesla or less
• Maximum spatial gradient field of 720 Gauss/cm or less
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.
Initiate timing using a stopwatch or timer at the moment
the device enters the microcatheter. Detachment must occur within the
specified reposition time.
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. 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
microcatheter used, fluoroscopy initiation may be delayed to minimize exposure.
25.
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.
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
microcatheter and damage the coil.
If the coil cannot be properly positioned
and detached within the specified time, simultaneously remove the device
and the microcatheter.
27.
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.
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
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
Coil Implant
Proximal end of coil is aligned with
microcatheter RO tip
Microcatheter Distal Tip RO Marker
Distal end of delivery
pusher
Microcatheter
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
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.
