FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELICAL DETACHABLE COIL
MDR report key: 2873561
·
Received December 14, 2012
Report
- Report Number
- 2029214-2012-00705
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 14, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A HORIZONTAL (M1) SEGMENT ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE THIRD COIL COULD NOT DETACH. A NEW COIL OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM HELICAL DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-1.5-2-HELIX | 9566616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |