FDA Adverse Event
Malfunction
Summary report: N
AXIUM HELICAL DETACHABLE COIL
MDR report key: 3073479
·
Received April 23, 2013
Report
- Report Number
- 2029214-2013-00403
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 4, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION.(B)(4).
Additional Manufacturer Narrative · 1
THE PUSHER ASSEMBLY WAS RETURNED WITHOUT THE INSTANT DETACHER AND THE IMPLANT COIL; THEREFORE, THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL COULD NOT BE DETACHED.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173858 | AXIUM HELICAL DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-2-2-HELIX | 9677106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |