FDA Adverse Event
Malfunction
Summary report: N
INJECTION GOLD PROBE BIPOLAR CATHETER
MDR report key: 1170183
·
Received September 11, 2008
Report
- Report Number
- 3005099803-2008-04500
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 12, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K961349
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT RETURNED BY THE FACILITY. THE CAUSE OF THE EVENT IS UNDETERMINED.
Description of Event or Problem · 1
DOCTOR REPORTED TO BOSTON SCIENTIFIC THAT THE TIP OF THE INJECTION GOLD PROBE BIPOLAR CATHETER DID NOT ENGAGE. THE EVENT CLARIFICATION ON FOLLOW UP EFFORT INDICATED THAT THE NEEDLE DID NOT EXTEND. THE CASE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INJECTION GOLD PROBE BIPOLAR CATHETER | KNS | BOSTON SCIENTIFIC CORPORATION | M00560150 | 11599012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |