FDA Adverse Event
Malfunction
Summary report: N
AXIUM PLATINUM HELICAL DETACHABLE COIL
MDR report key: 3800165
·
Received May 8, 2014
Report
- Report Number
- 2029214-2014-00249
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 18, 2014
- 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 HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Additional Manufacturer Narrative · 1
THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION WITH THE IMPLANT COIL STILL ATTACHED CONTRADICTING THE REPORTED EVENT DESCRIPTION; THEREFORE, THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. THERE WAS NO PREMATURE DETACHMENT OF THE IMPLANT COIL. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).
Description of Event or Problem · 1
DURING THE PREPARATION, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED AS IT WAS BEING HYDRATED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS THE DEVICE WAS NOT USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279268 | AXIUM PLATINUM HELICAL DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-4-8-HELIX | 9743243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |