How Supplied - COOK Medical MReye Instrucciones De Uso

PRODUCT RECOMMENDATIONS
Delivery Catheter and Wire Guide Recommendations for
Embolization Coils
Coil Size
Diameter
.025 inch
.035 inch
.038 inch
Coil Delivery Technique and Coil Size Selection
Long-term occlusion depends on achieving cross-sectional occlusion of the
blood vessel, and coaxial catheters provide the ability to control placement
of coils and permanent occlusion. The combination of the coaxial technique
and either the anchor or scaffold technique significantly enhances stability of
coil deployment.
• Coaxial technique: The use of an outer guiding sheath/catheter is the
most important step in preventing coil elongation and uncertain long-
term occlusion. The outer guiding sheath/catheter provides support, and
the inner catheter provides finer selective maneuvers. (Fig. 3)
• Anchor technique: The anchor technique provides safe and distal
occlusion when there is a question about instability of coils. At least 2 cm
of a coil is advanced into the side branch, which is normally sacrificed.
The rest of the coil is then deployed just proximal to that side branch, and
additional coils are packed. (Fig. 4) Note : Use a coil longer than 10cm for
anchor technique.
• Scaffold technique: The scaffold technique is used for high-flow vessels
when there is concern about migration of a softer coil. An Inconel coil is
placed initially. Then, several Inconel coils or platinum coils (soft coils) may
be packed within the scaffold. (Fig. 5)
In general, the first coil selected should have a diameter that is 20% larger, or
at least 2 mm oversized, than the vessel that is being occluded.
INSTRUCTIONS FOR USE
NOTE: The embolization coil is supplied preloaded in the loading cartridge.
1. Perform an angiogram prior to embolization to determine optimal
catheter position.
2. Firmly grasp the loading cartridge between thumb and forefinger.
Introduce the metal end of the loading cartridge into the base of the
catheter hub. Lock loading cartridge onto catheter hub by rotating Luer
lock adapter clockwise. (Fig. 1)
3. Maintaining position of the cartridge, advance the stiff portion of the
wire guide into the loading cannula. Push the coil into the first 20 to 30
centimeters of the angiographic catheter. (Fig. 2) Remove the wire guide
and loading cartridge.
4. With the flexible tip of the wire guide, advance the embolization coil to
the tip of the catheter. Verify position of the angiographic catheter prior
to deployment.
5. Deploy the coil by advancing the wire guide past the tip of the catheter.
6. Perform final angiogram to confirm coil position within target vessel.

HOW SUPPLIED

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened and undamaged. Do not use
the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from
package inspect the product to ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature. Refer to your local Cook sales representative for
information on available literature.
V. P. Chuang, S. Wallace, C. Gianturco: "A New Improved Coil for Tapered Tip
Catheter for Arterial Occlusion, " Radiology, 135 (1980), 507-509.
Catheter Type & Size
SCR3.0B
HNB4.0-35
HNB4.1-35
HNB[R]5.0-35
SCBR4.0-35
SCBR5.0-35
HNB[R]5.0-38
HNB[R]6.0-38
SCBR4.0-38
SCBR5.0-38
9
Wire Guide Type
& Size
TSF-25
TSFB-25
TSF-35
TSFB-35
TSFBP-35
TSFNA-35
TSFNB-35
TSF-38
TSFB-38
TSFNA-38
TSFNB-38