FDA Adverse Event
Malfunction
Summary report: N
BARD PERIPHERAL VASCULAR INC
MDR report key: 692277
·
Received March 7, 2006
Report
- Report Number
- MW1038219
- Event Type
- Malfunction
- Date Received
- March 7, 2006
- Date of Event
- March 2, 2006
- Report Date
- March 2, 2006
- Manufacturer
- BARD PERIPHERAL VASCULAR INC
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMING DIALYSIS FISTULAGRAM WITH PTA. DILATED THE CONQUEST 3 DIFFERENT TIMES AND THE BALLOON BURST. BALLOON WAS USED IN NORMAL WAY. NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD PERIPHERAL VASCULAR INC | CONQUEST | LIT | BARD PERIPHERAL VASCULAR INC | * | P3L P0058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |