FDA Adverse Event
Malfunction
Summary report: N
GREENFIELD VENA CAVA FILTER
MDR report key: 970516
·
Received June 9, 2006
Report
- Report Number
- 6000118-2006-00041
- Event Type
- Malfunction
- Date Received
- June 9, 2006
- Date of Event
- May 8, 2006
- Report Date
- May 11, 2006
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
SAME CASE AS MFR'S REPORT #6000118-2006-42. IT WAS REPORTED THAT DURING A GREENFIELD VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER PARTIALLY DEPLOYED PREMATURELY. THE FILTER WAS RETRIEVED AND THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER GREENFIELD VENA CAVA FILTER. THE SECOND FILTER ALSO DEPLOYED PREMATURELY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MFR'S FILTER. THE PT CONDITION IS REPORTED AS 'FINE'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENFIELD VENA CAVA FILTER | VENA CAVA FILTER | DTK | BOSTON SCIENTIFIC | NA | 8389567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |