FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1200046
·
Received October 15, 2008
Report
- Report Number
- 2029214-2008-00180
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 25, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION AND CONFIRMED THE IMPLANT COIL HAD DETACHED, BUT THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
DURING A COILING TREATMENT PROCEDURE, IT WAS REPORTED THE COIL COULD NOT BE DETACHED. DURING REMOVAL, THE COIL DETACHED IN THE Y-CONNECTOR. 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-1.5-2-HELIX | 50569705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |