0.018” and 0.035” Fibered Platinum Coils

0.018" and 0.035" Fibered Platinum Coils

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Refer to the Instructions for Use for complete instructions for use.

0.018” Straight-18, Figure 8-16, Multi-Loop-18, Complex Helical-18 Fibered Platinum Coils

Indications for Use:
Boston Scientific’s 0.018 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Contraindications:
None known

Warnings:
Recanalization has been observed with the usage of some coils. Angiographic follow-up is recommended to ensure continued occlusion.

To date, there have been no reports of adverse events associated with MRI procedures conducted on patients with platinum coils in their neurovasculature or peripheral vasculature. However, compatibility with Magnetic Resonance Imaging (MRI) has not been established, and the degree of imaging distortion resulting from the coil has not been measured.

Never advance the coil pusher after the coil has been deployed to avoid risk of damaging vessel. If vessel damage occurs follow institutional protocols.

Adverse Events:
Potential complications include but are not limited to:

• hematoma at the site of entry
• vessel perforation
• emboli
• hemorrhage
• ischemia or vasospasm
• clot formation at tip of catheter & subsequent dislodgement
• nerve and vessel dissection & perforation
• pain
• infection necessitating medical intervention
• claudication
• tissue necrosis
• undesirable clot formation of the vasculature
• foreign body reactions necessitating medical intervention

Precautions:

• Compatibility with microcatheters other than the Boston Scientific microcatheters specified herein has not been established.
• Do not use microcatheters , coil pushers or coils that have been damaged in any way.
• 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.

.035” Type Fibered Platinum Coils

Indications:
.035” Type Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Contraindications:
None known
Warnings:
Never advance the guidewire after coil has been deposited. Advancing the guidewire after the coil has been deposited risks damaging the vessel.

To date, there have been no reports of adverse events associated with Magnetic Resonance Imaging (MRI) procedures conducted on patients with platinum coils in their neurovasculature. However, compatibility with MRI has not been established, and the degree of imaging distortion resulting from the coil has not been measured.

In preclinical studies, the use of this device has been associated with a minor chronic inflammation of a giant cell foreign body reaction. Although inflammation of this type has not been observed in humans, the long term clinical significance of this type of inflammatory response, if any, is unknown. Therefore, we do not recommend that this device be used for permanent occlusion.
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.

Multiple embolization procedures may be required to achieve the desired occlusion of some vessels.

Potential Adverse Effects:
Potential complications include but are not limited to: hematoma at the site of entry, vessel perforation or rupture, emboli, hemorrhage, ischemai or vasospasm, neurological deficits including strokes and possibly death.

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions:
Verify repeatedly that the distal shaft of the coil delivery catheter is not under stress before coil deployment. Axial compression of tension forces may be stored in the catheter causing the tip to move during coil delivery.

The uses of high quality, digital subtraction fluoroscopic road mapping helps to monitor the catheter position in relation to vessel bifurcations and is a useful tool in the selection of the appropriate delivery site an the corresponding coil size.

Do not advance the coil with force if the coil becomes lodged within the catheter. Determine the cause of resistance and replace the catheter and the coil when necessary.

If resistance is encountered when withdrawing the 0.035” guidewire, draw back on the catheter simultaneously until the guidewire can be removed without resistance.

Contrast medium may cause the coil to change its position. All injections should be made in a slow, controlled fashion.

Replace catheter frequently if increased resistance is noted during coil delivery.