FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1963783
·
Received December 22, 2010
Report
- Report Number
- 2029214-2010-00272
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS. EVENTUALLY, THE COIL DETACHED INSIDE THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM WITH THE PUSHWIRE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-2-4-3D | 7298056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |