FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1193408
·
Received October 7, 2008
Report
- Report Number
- 2029214-2008-00177
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- August 28, 2008
- Report Date
- September 9, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE PUSHER ASSEMBLY WAS FOUND SEVERELY KINKED. WHEN ADVANCING THE COIL THROUGH THE CATHETER, THE KINKS WERE ALLOWED TO STRAIGHTEN. AS THE KINKS STRAIGHTENED, THE RELEASE WIRE PULLED INTO THE DISTAL TIP OF THE PUSHER ASSEMBLY CAUSING THE IMPLANT TO DETACH.
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. DURING COIL DELIVERY, IT WAS REPORTED THE COIL PREMATURELY DETACHED AND WAS SUCCESSFULLY RETRIEVED BY WITHDRAWING THE CATHETER. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM HELIX DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-2-6-HELIX | 5500590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |