FDA Adverse Event
Malfunction
Summary report: N
CASHMERE COMPLEX CERECYTE COIL
MDR report key: 1041334
·
Received April 21, 2008
Report
- Report Number
- 1041334
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 21, 2008
- Manufacturer
- MICRUS ENDOVASCULAR CORP.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
COIL DID NOT UNSHEATH PROPERLY DURING PREPARATION FOR USE IN PATIENT. ANOTHER COIL WAS SUBSTITUTED, AND PATIENT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CASHMERE COMPLEX CERECYTE COIL | COIL | HCG | MICRUS ENDOVASCULAR CORP. | CRC140615-30 | F39924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |