FDA Adverse Event
Malfunction
Summary report: N
CONQUEST PTA BALLOON DILATION CATHETER
MDR report key: 3830202
·
Received May 12, 2014
Report
- Report Number
- 2020394-2014-00213
- Event Type
- Malfunction
- Date Received
- May 12, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 16, 2014
- 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PTA BALLOON DILATION CATHETER SHAFT BROKE DURING RETRACTION INTO THE SHEATH. THE CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283295 | CONQUEST PTA BALLOON DILATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | REXK2242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female |