FDA Adverse Event
Malfunction
Summary report: N
MICRUS MICROCOIL SYSTEM
MDR report key: 1160739
·
Received September 5, 2008
Report
- Report Number
- 2954740-2008-00005
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 8, 2008
- Manufacturer
- MICRUS ENDOVASCULAR CORPORATION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED IN 2008. A F/U SUMMARY REPORT OF EVAL WILL BE SUBMITTED/MAILED POST EVAL COMPLETION.
Description of Event or Problem · 1
AS THE PHYSICIAN ADVANCED THE COIL INTO THE ANEURYSM, THE PHYSICIAN HAD NOTICED THAT THE COIL DETACHED PREMATURELY. IN AN ATTEMPT TO SNARE THE COIL OUT OF THE MICROCATHETER, THE COIL SNAPPED AND ONLY HALF OF THE COIL WAS RETRIEVED. THE REMAINDER OF THE COIL WAS LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRUS MICROCOIL SYSTEM | EMBOLIC COIL | HCG | MICRUS ENDOVASCULAR CORPORATION | PRESIDIO MICROCOIL | F43052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |