FDA Adverse Event
Malfunction
Summary report: N
CROSSER RECANILIZATION CATHETER
MDR report key: 3040583
·
Received March 14, 2013
Report
- Report Number
- 2020394-2013-00069
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 11, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K091119
- 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 A RECANALIZATION CATHETER COULD NOT CROSS THE OCCLUSION. AS THE CATHETER WAS BEING RETRACTED, APPROXIMATELY 1.5 CM OF THE TIP OF THE CATHETER DETACHED IN THE CTO. NO INTERVENTION WAS ATTEMPTED AND THE DETACHED CATHETER SEGMENT REMAINS EMBEDDED IN THE PT. NO FURTHER TREATMENT WAS PERFORMED. THE PT IS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108307 | CROSSER RECANILIZATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | FCWL10012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |