Target Detachable Coil Detachment Procedure; How Supplied; Handling And Storage; Warranty - Stryker Target Gebrauchsanweisung

12. After Target Detachable Coil placement and prior to coil detachment, verify
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under fluoroscopy that the coil is not protruding into the parent vessel. If any
coil protrusion can be seen, reposition the coil until there are no signs of coil
protrusion. If the coil cannot be placed without protrusion, remove the coil
and replace it with another more appropriately sized coil (one with a smaller
secondary diameter).
warning: Verify there is no coil loop protrusion into the parent vessel after
coil placement and prior to coil detachment. Coil loop protrusion after coil
placement may result in thromboembolic events if the coil is detached.
13. After Target Detachable Coil placement and prior to coil detachment, verify
under fluoroscopy that there is no undesirable movement of the coil. If any
undesirable movement can be seen, remove the coil and replace it with
another more appropriately sized coil (one with a larger secondary diameter).
warning: Verify there is no movement of the coil after coil placement and prior
to coil detachment. Movement of the coil after coil placement may indicate
that the coil could migrate once it is detached.

7.5 Target Detachable Coil Detachment Procedure

note: Refer to the InZone Detachment System Directions for Use (available
®
within InZone Detachment System packaging) for coil detachment instructions.
1. Proceed with detachment per instructions in the InZone Detachment System DFU.
warning: Failure to properly close the RHV compression fitting over the
delivery wire before attaching the InZone Detachment System could result in
coil movement, aneurysm rupture or vessel perforation.
Caution: Do not use detachment systems other than the InZone Detachment
System, M00345100950.
Caution: Increased detachment times may occur when:
• Other embolic agents are present.
• Delivery wire and microcatheter markers are not properly aligned.
• Thrombus is present on the coil detachment zone.
2. Once cycle complete has been signaled, verify under fluoroscopy that the coil
has detached by performing the following:
• Remove the InZone Detachment System from the delivery wire and loosen
the microcatheter RHV.
• Under fluoroscopy, slowly pull back on the delivery wire making sure that
the coil does not move.
warning: Advancing the delivery wire beyond the microcatheter tip once the
coil has been detached involves risk of aneurysm or vessel perforation.
3. If the coil moves during delivery wire retraction, perform the following:
• Confirm that flush is set up properly
• Advance the delivery wire to reposition the coil and establish appropriate
wire and microcatheter marker alignment.
• Tighten the RHV around the delivery wire
Black (K) ∆E ≤5.0
• Follow instructions in the InZone Detachment System DFU to detach the coil
• Verify coil separation under fluoroscopy as above. Repeat as necessary up
to 4 times.
• If the coil does not detach after trying 4 times, remove the coil and replace
it with a new Target Detachable Coil and repeat the steps outlined above
(starting from Section 7.3.4).
4. Once coil detachment has been fluoroscopically confirmed, slowly withdraw
the delivery wire from the microcatheter.
5. If additional coil placement is required, repeat the steps outlined above
(starting from Section 7.3.4).
6. Once the procedure is over, discard any used materials, including the
detachment system, and packaging.
warning: The long term effect of this product on extravascular tissues has
not been established so care should be taken to retain this device in the
intravascular space.
warning: After use, dispose of product and packaging in accordance with
hospital, administrative and/or local government policy.

8. How sUPPlIeD

Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
sterile: This device is sterilized and non-pyrogenic using an ethylene oxide (EO)
process.
Contents: One (1) Target Detachable Coil.

Handling and storage

Store in a cool, dry, dark place.

warranTy

Stryker Neurovascular 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 Stryker Neurovascular's control directly affect the instrument and
the results obtained from its use. Stryker Neurovascular's obligation under this
warranty is limited to the repair or replacement of this instrument and Stryker
Neurovascular shall not be liable for any incidental or consequential loss, damage
or expense directly or indirectly arising from the use of this instrument. Stryker
Neurovascular neither assumes, nor authorizes any other person to assume for it,
any other or additional liability or responsibility in connection with this instrument.
stryker neurovascular 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.
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