FDA Adverse Event
Malfunction
Summary report: N
CONQUEST PTA BALLOON DILATATION CATHETER
MDR report key: 3014293
·
Received February 20, 2013
Report
- Report Number
- 2020394-2013-00034
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 12, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K083657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THE PTA BALLOON PARTIALLY DETACHED FROM THE CATHETER WHILE BEING RETRACTED INTO THE SHEATH. THE CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT WITHOUT INCIDENT. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74532 | CONQUEST PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | REWH1703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |