FDA Adverse Event
Malfunction
Summary report: N
RIVAL PTA BALLOON DILATATION CATHETER
MDR report key: 2142552
·
Received June 20, 2011
Report
- Report Number
- 2020394-2011-00141
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 20, 2011
- Report Date
- June 3, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K052149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PTA BALLOON CATHETER COULD NOT BE REMOVED THROUGH THE 6F SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS ONE UNIT. ANOTHER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIVAL PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | GFUK4093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |