FDA Adverse Event
Injury
Summary report: N
5 FR SL POWERPICC WITH 70CM NITINOL GUIDEWIRE
MDR report key: 2925125
·
Received January 17, 2013
Report
- Report Number
- 3006260740-2013-00030
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K033389
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWK0239 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
WIRE UNCOILED UPON REMOVAL. A PIECE DID BREAK OFF IN THE PT AND HAS NOT BEEN RETRIEVED. THE RADIOLOGIST IS NOT CONCERNED WITH THE PIECE LEFT IN THE PT, SAYS THAT IT IS IN THE SOFT TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26252 | 5 FR SL POWERPICC WITH 70CM NITINOL GUIDEWIRE | LJS | C. R. BARD INC. (BASD) | REWK0239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |