Interlock and IDC Detachable Embolization Coils
Indications, Safety, and Warnings
Fibered IDC – DFU 90962110
Interlock Fibered IDC Occlusion System – DFU 90961055
IDC Interlocking Detachable Coil – DFU 90964372
INTENDED USE/INDICATIONS FOR USE
The Interlock IDC Occlusion System is a modified interlocking detachable coil. The Interlock IDC Occlusion Systems are indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. These devices are not intended for neurovascular use.
Do not attempt to use the Interlock - 35 Fibered IDC Occlusion System with a soft-walled delivery catheter.
Do not advance the Interlock IDC Occlusion System if it becomes lodged within the catheter. Determine the cause of the resistance and replace the catheter and coil if necessary.
The complications that may result from a peripheral embolization procedure include, but are not limited to:
- Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, nerve and vessel dissection or perforation, etc.)
- Infection necessitating medical intervention
- Foreign body reactions necessitating medical intervention
- Tissue necrosis
- Undesirable clot formation of the vasculature
- Temporary neurological deficit