FDA Adverse Event
Injury
Summary report: N
MERIDIAN FILTER SYSTEM - FEMORAL
MDR report key: 2872136
·
Received December 5, 2012
Report
- Report Number
- 2020394-2012-00277
- Event Type
- Injury
- Date Received
- December 5, 2012
- Date of Event
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K112497
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST FILTER IMPLANT DURING THE SCHEDULED FILTER RETRIEVAL, FLUOROSCOPIC IMAGING DEMONSTRATED A DETACHED FILTER LIMB EMBEDDED IN THE IVC WALL. THE FILTER WAS SUCCESSFULLY REMOVED WITH A SNARE. APPROXIMATELY FIVE DAYS LATER, IMAGING DEMONSTRATED THE DETACHED LIMB IN THE RIGHT VENTRICLE. A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE DETACHED LIMB FROM THE VENTRICLE. THE PT WAS REPORTED TO BE ASYMPTOMATIC AND THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDIAN FILTER SYSTEM - FEMORAL | DTK | BARD PERIPHERAL VASCULAR, INC. | GFWC2303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |