FDA Adverse Event
Death
Summary report: N
BARD RECOVERY FILTER
MDR report key: 1589582
·
Received January 25, 2010
Report
- Report Number
- MW5014526
- Event Type
- Death
- Date Received
- January 25, 2010
- Date of Event
- January 11, 2010
- Report Date
- January 25, 2010
- Manufacturer
- BARD PERIPHERAL VASCULAR
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FLUOROSCOPY IN 2008 FOUND IVC FILTER SEGMENT IN THE RIGHT VENTRICLE. THIS WAS RE-EVALUATED IN (B) (6). 2009. THE TINE BROKEN FROM THE IVC FILTER REMAINED IN THE RIGHT VENTRICLE. IN (B) (6) 2010, THE PATIENT DIED AT HOME. NO AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD RECOVERY FILTER | IVC FILTER | DTK | BARD PERIPHERAL VASCULAR | RF-048F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |