FDA Adverse Event
Malfunction
Summary report: N
DORADO PTA BALLOON DILATATION CATHETER
MDR report key: 3131541
·
Received May 16, 2013
Report
- Report Number
- 2020394-2013-00155
- Event Type
- Malfunction
- Date Received
- May 16, 2013
- Date of Event
- May 10, 2013
- Report Date
- May 13, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K072283
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AT 12 ATM DURING THE FIRST INFLATION IN THE DISTAL CEPHALIC VEIN JUNCTION WITH THE SUBCLAVIAN VEIN. DURING RETRACTION, THE BALLOON COULD NOT BE REMOVED FROM THE 6F INTRODUCER SHEATH. BOTH WERE REMOVED SIMULTANEOUSLY FROM THE PATIENT WITHOUT FURTHER COMPLICATIONS. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218245 | DORADO PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | 93CX0208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |