FDA Adverse Event
Malfunction
Summary report: N
CRUISER-18
MDR report key: 4110268
·
Received September 12, 2014
Report
- Report Number
- 3006010712-2014-00007
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- July 24, 2014
- Report Date
- August 15, 2014
- Manufacturer
- BRIVANT, LTD.
- Product Code
- DQX
- PMA / PMN Number
- K102211
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE COATING FLAKED OFF THE WIRE DURING REINTRODUCTION OF THE WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565172 | CRUISER-18 | GUIDEWIRE | DQX | BRIVANT, LTD. | 357261 | 10326888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |