FDA Adverse Event
Injury
Summary report: N
G2 FILTER SYSTEMS - JUGULAR
MDR report key: 3761172
·
Received December 31, 2013
Report
- Report Number
- 2020394-2013-00472
- Event Type
- Injury
- Date Received
- December 31, 2013
- Date of Event
- August 24, 2007
- Report Date
- December 3, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K052578
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS NOT BEEN PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 AND FILTER TILT WERE DISCOVERED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682646 | G2 FILTER SYSTEMS - JUGULAR | VENA CAVA FITER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention | COUMADIN, LOVENOX |