FDA Adverse Event
Malfunction
Summary report: N
VACCESS PTA BALLOON DILATATION CATHETER
MDR report key: 2142550
·
Received June 20, 2011
Report
- Report Number
- 2020394-2011-00136
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Report Date
- May 27, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- LIT
- PMA / PMN Number
- K073472
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 DURING ANGIOPLASTY OF THE SUBCLAVIAN VEIN IN A RIGHT ARM AVFISTULA, THE PTA BALLOON WOULD NOT FULLY DEFLATE AFTER THE FIRST INFLATION AT 10 ATM. REPORTEDLY, AFTER 3 TO 5 MINUTES, THE BALLOON WOULD ONLY DEFLATE HALF WAY. THE BALLOON CATHETER WAS CUT AND THE BALLOON WAS REMOVED THROUGH THE INTRODUCER SHEATH WITHOUT FURTHER INCIDENT. A NEW WIRE, SHEATH, AND BALLOON CATHETER WERE USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VACCESS PTA BALLOON DILATATION CATHETER | LIT/DQY | LIT | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |