FDA Adverse Event
Injury
Summary report: N
VASCUTRAK 2 PTA BALLOON DILATATION CATHETER
MDR report key: 3131444
·
Received May 10, 2013
Report
- Report Number
- 2020394-2013-00146
- Event Type
- Injury
- Date Received
- May 10, 2013
- Report Date
- May 6, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K082343
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN 80MM SEGMENT OF THE PTA BALLOON DILATATION CATHETER DETACHED IN THE DISTAL SFA AND REMAINED IN THE PT. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED CATHETER, THE PT WAS REPORTED TO BE DOING WELL POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209330 | VASCUTRAK 2 PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | GFUJ3441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |