FDA Adverse Event
Malfunction
Summary report: N
RECOVERY FILTER SYSTEM
MDR report key: 2100241
·
Received May 16, 2011
Report
- Report Number
- 2020394-2011-00107
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Report Date
- February 9, 2010
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K031328
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST FILTER IMPLANT, IMAGING DEMONSTRATED THAT A FILTER LIMB MAY HAVE DETACHED FROM THE REST OF THE FILTER. THE DETACHED COMPONENT APPEARS TO BE LODGED IN THE PSOAS MUSCLE. THE DISCOVERY WAS INCIDENTAL. AN ATTEMPT TO RETRIEVE THE IVC FILTER WAS PERFORMED, HOWEVER PROVED UNSUCCESSFUL. NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECOVERY FILTER SYSTEM | DTK | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |