Directions For Use - Stryker GDC 360º Gebrauchsanweisung

2. Attach a second RHV to the hub of the 2-tip infusion catheter. Attach a 1-way stopcock to the side arm of
the RHV, then connect a line for continuous flushing of appropriate solution.
One drop from the pressure bag every 3-5 seconds is suggested.
3. Check that all fittings are secure so that air is not introduced into guiding or 2-tip infusion catheters
during continuous flush.
3-Way
Stopcock
Guiding
Catheter Hub
Guiding
Catheter
1st RHV
Line to flush
Guiding Catheter
Femoral
Sheath
Proximal
Microcatheter
Distal
Marker
Microcatheter
Marker
Infusion Catheter
GDC® 360˚ Platinum Coils
Figure 1. example of Continuous Flush setup
InZone® DetaCHMent sYsteM preparatIon For Use (For M00345100940 or M00345100950)
If using the InZone Detachment System to detach GDC 360º Coils, refer to the InZone Detachment System
Directions for Use packaged with each device for "Required Additional Items" and "Removal from Packaging"
instructions.

DIreCtIons For Use

Carefully catheterize the lesion to be treated. The access system should include a guiding catheter of sufficient
inner diameter (ID) to accept a 2-tip infusion catheter and to permit adequate contrast infusion around the 2-tip
infusion catheter for fluoroscopic road mapping. Measure the size of the aneurysm to be treated and select an
appropriately sized GDC 360° Detachable Coil.
1. Slowly and simultaneously remove the GDC 360° Coil and introducer sheath from the dispenser coil.
Inspect proximal section of delivery wire for irregularities. If irregularities exist, replace with a new
GDC 360° Detachable Coil.
warning: Damaged delivery wires may cause vessel injury or unpredictable distal tip response during
coil deployment.
2. To unlock the Twist-Lock mechanism on the introducer sheath, gently pinch the introducer sheath on
both sides of the Twist-Lock mechanism and rotate proximal side counter-clockwise (Figure 2). This
releases the delivery wire/coil assembly to move freely within the introducer sheath.
Distal
Figure 2. Unlock via Counter-Clockwise rotation
Line to flush
solution
2nd RHV
2-Tip
Line to flush
Catheter Hub
solution
1-Way
Stopcock
2-Tip
Proximal
Distal
Figure 3. Lock via Clockwise rotation
3. Slowly advance the coil out of the introducer sheath and into the palm of a gloved hand and inspect for:
• Irregularities at the coil detachment zone, e.g., delivery wire kinking
• Loss of circular memory (shape)
If any of these irregularities exist, replace with a new coil.
warning: Utilization of damaged coils may affect coil delivery to, and stability inside, the vessel or
aneurysm, possibly resulting in coil migration and/or stretching.
4. Gently immerse the coil, including the coil junction, in heparinized saline. Take care not to stretch the
coil during maneuvers in order to preserve the circular memory. While still immersed in the heparinized
saline, gently retract the distal tip of the coil into the introducer sheath approximately 1-2 cm. Verify that
the coil distal tip is at the tapered end of introducer sheath.
5. Lock the Twist-Lock mechanism with a clockwise rotation (see Figure 3) and insert the tapered distal
end of the introducer sheath through the RHV and into the hub of the 2-tip infusion microcatheter until
the sheath is firmly seated. A slight buckling of the introducer sheath indicates proper positioning.
Tighten the RHV around the introducer sheath to prevent the back flow of blood, but not so tight as to
damage the coil during its introduction into the catheter.
6. Unlock the Twist-Lock mechanism and transfer the GDC 360° Detachable Coil into the catheter by
advancing the delivery wire in a smooth, continuous manner. This procedure is best accomplished by
two people: one to maintain the introducer sheath inside the RHV and 2-tip infusion catheter hub and
one to hold the sheath straight and advance the coil.
Once the flexible portion of the delivery wire has entered the catheter shaft, loosen the RHV and remove
the introducer sheath over the delivery wire's proximal end. Once completed, tighten the RHV around the
delivery wire. Leaving the introducer sheath in place will interrupt normal infusion of flush solution and
allow back flow of blood into the catheter. Do not discard the introducer sheath until after the GDC 360°
Detachable Coil has been positioned and detached.
7. Visually verify that the flush solution is infusing normally. Once confirmed, loosen the RHV enough to
advance the delivery wire, but not so much as to compromise the continuous infusion.
8. Advance the coil under fluoroscopy and position carefully at the desired site. If coil placement is
unsatisfactory, slowly withdraw by pulling on the delivery wire, then slowly advance again to reposition
the coil. If the coil size is inappropriate, remove and replace with an appropriately sized coil. (See Coil
Selection section.)
precautions
Advance and retract the coil slowly and smoothly, especially in tortuous anatomy. Remove the coil if
unusual friction or "scratching" is noted. If friction is noted in a second coil, carefully examine both coil
and the catheter for possible damage such as catheter shaft buckling or kinking, or improperly fused joint.
Do not advance the coil with force if the coil becomes lodged within or outside the 2-tip infusion
catheter. Determine the cause of resistance and remove the system when necessary.
If resistance is encountered when withdrawing the delivery wire, draw back on the infusion catheter
simultaneously until the delivery wire can be removed without resistance.
If resistance is noted during coil delivery, remove the catheter/coil system and check for possible
damage to the catheter.
warning: Do not rotate delivery wire during or after delivery of the coil into the aneurysm. rotating the
GDC 360° Detachable Coil delivery wire may result in a stretched coil or premature detachment of the
coil from the delivery wire, which could result in coil migration.
9. Continue to advance the GDC 360° Detachable Coil until the radiopaque proximal marker on the
delivery wire is exactly distal to the proximal marker on the 2-tip infusion catheter (see Figure 4
below). Tighten O-ring on RHV to prevent movement of the delivery wire and proceed with detachment
per instructions below.
3
Proximal
Black (K) ∆E ≤5.0