FDA Adverse Event
Malfunction
Summary report: N
PRESIDIO
MDR report key: 1162759
·
Received September 15, 2008
Report
- Report Number
- MW5008315
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 15, 2008
- Manufacturer
- MICRUS ENDOVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
COIL DELIVERY WIRE BROKE DURING MANIPULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESIDIO | ANEURYSM MICROCOIL | HCG | MICRUS ENDOVASCULAR | PC4181846-30 | 32985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |