FDA Adverse Event
Malfunction
Summary report: N
RIVAL PTA BALLOON DILATATION CATHETER
MDR report key: 2142541
·
Received June 20, 2011
Report
- Report Number
- 2020394-2011-00137
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K052149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RETURNED AND IS PENDING EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PTA BALLOON DETACHED FROM THE CATHETER SHAFT UPON RETRACTING THE BALLOON CATHETER THROUGH A 6F INTRODUCER SHEATH. REPORTEDLY, THERE WERE DIFFICULTIES ADVANCING THE CATHETER TO THE TREATMENT SITE. HOWEVER, THE BALLOON WAS INFLATED AND DEFLATED WITHOUT ISSUES. UPON REMOVING THE BALLOON CATHETER THROUGH THE SHEATH, THE BALLOON COMPLETELY DETACHED FROM THE CATHETER SHAFT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIVAL PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |