FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1231140
·
Received November 12, 2008
Report
- Report Number
- 2029214-2008-00196
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 15, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
Narratives
Additional Manufacturer Narrative · 1
THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION AND CONFIRMED THE IMPLANT COIL HAD DETACHED AS INTENDED. IN ADDITION, A LARGE AMOUNT OF BLOOD WAS FOUND ON THE PUSHER ASSEMBLY. BASED ON THE INVESTIGATION AND THE REPORT, THE LARGE AMOUNT OF BLOOD FOUND ON THE PUSHER ASSEMBLY WAS LIKELY THE CAUSE FOR THE COIL DELAY DETACHMENT.
Description of Event or Problem · 1
COILING TREATMENT OF A MCA ANEURYSM. IT WAS REPORTED THE COIL COULD NOT BE DETACHED. UPON REMOVAL, THE COIL DETACHED INSIDE 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-2-1-HELIX | 4207128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |