FDA Adverse Event
Malfunction
Summary report: N
G2 FILTER SYSTEM - FEMORAL
MDR report key: 3761229
·
Received December 31, 2013
Report
- Report Number
- 2020394-2013-00466
- Event Type
- Malfunction
- Date Received
- December 31, 2013
- Date of Event
- May 6, 2011
- Report Date
- October 10, 2017
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K062887
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENA CAVA FILTER, IVC PERFORATION WAS DISCOVERED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682631 | G2 FILTER SYSTEM - FEMORAL | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFQD3720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | OXYBUTYNIN| OXYBUTYNIN |