FDA Adverse Event
Malfunction
Summary report: N
MERIDIAN FILTER SYSTEM - FEMORAL
MDR report key: 2904616
·
Received December 5, 2012
Report
- Report Number
- 2020394-2012-00274
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K112497
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 APPROXIMATELY TWO MONTHS POST-IMPLANT, DURING A SCHEDULED FILTER RETRIEVAL, FLUOROSCOPY DEMONSTRATED A DETACHED ARM. DURING THE RETRIEVAL, THE REMAINING PORTION OF THE DETACHED ARM FRACTURED AT THE APEX TRAVELING TO THE PULMONARY ARTERY. THE FILTER WAS RETRIEVED SUCCESSFULLY; HOWEVER, THE DETACHED ARM REMAINS EMBEDDED IN THE IVC WALL AND THE REMAINING FRACTURED ARM WAS LEFT IN THE PULMONARY ARTERY. NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDIAN FILTER SYSTEM - FEMORAL | DTK | BARD PERIPHERAL VASCULAR, INC. | GFWE2957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |