FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1193407
·
Received October 7, 2008
Report
- Report Number
- 2029214-2008-00178
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 23, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONLY THE COIL IMPLANT WAS RETURNED FOR EVALUATION, AND THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED, THE COIL COULD NOT BE DETACHED. WHILE PULLING IT BACK, 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-2-2-HELIX | 5038350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |