FDA Adverse Event
Malfunction
Summary report: N
INJECTION GOLD PROBE BIPOLAR CATHETER
MDR report key: 1203292
·
Received October 17, 2008
Report
- Report Number
- 3005099803-2008-05379
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Report Date
- September 19, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K961349
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DATE OF THE EVENT IS UNK. BOSTON SCIENTIFIC WAS MADE AWARE THAT AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS USED DURING AN UPPED ESOPHAGOGASTRODUODENOSCOPY (EGD) TO TREAT A "BLEED." IT WAS NOTED THAT THE CATHETER WAS KINKED. IT IS NOT KNOWN IF THE KINK WAS IN THE PROBE CATHETER OR AT THE HANDLES. THIS DEVICE WAS NEVER IN CONTACT WITH THE PT. THE CASE WAS COMPLETED WITH A SECOND INJECTION GOLD PROBE BIPOLAR CATHETER. THE PT'S CONDITION WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INJECTION GOLD PROBE BIPOLAR CATHETER | KNS | BOSTON SCIENTIFIC CORPORATION | M00560150 | 11819247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |