FDA Adverse Event
Malfunction
Summary report: N
VACCESS PTA BALLOON DILATATION CATHETER
MDR report key: 2150385
·
Received June 8, 2011
Report
- Report Number
- 2020394-2011-00134
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 19, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- LIT
- PMA / PMN Number
- K073472
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AT APPROXIMATELY 10-12 ATM WHILE BEING USED TO POST DILATE A STENT IN THE SUBCLAVIAN VEIN. REPORTEDLY, THE BALLOON BECAME CAUGHT ON THE STENT. AN INTRODUCER SHEATH WAS ADVANCED OVER THE BALLOON, AND BOTH THE BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VACCESS PTA BALLOON DILATATION CATHETER | LIT / DQY | LIT | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |