FDA Adverse Event
Malfunction
Summary report: N
OCCLUSION BALLOON CATHETER
MDR report key: 482418
·
Received September 4, 2003
Report
- Report Number
- 6000118-2003-00037
- Event Type
- Malfunction
- Date Received
- September 4, 2003
- Date of Event
- August 13, 2003
- Report Date
- August 14, 2003
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PIROR TO A DIAGNOSTIC AORTIC RUN-OFF PROCEDURE THE OCCLUSION BALLOON LEAKED. WHILE THE BALLOON WAS BEING PREPPED IT WAS NOTED THAT SOLUTION WAS LEAKING. THE DEVICE WAS NOT USED DURING THE PROCEDURE. A SECOND OCCLUSION BALLOON WAS TRIED AND THE SAME PROBLEM OCCURRED AGAIN. THE SECOND BALLOON ALSO WAS NOT USED DURING THE PROCEDURE. A THIRD OCCLUSION BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT IS REPORTED AS 'FINE' FOLLOWING THE PROCEDURE; NO INJURY OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCCLUSION BALLOON CATHETER | OCCLUSION BALLOON CATHETER | DQT | BOSTON SCIENTIFIC | NA | 5499591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |