FDA Adverse Event
Malfunction
Summary report: N
GREENFIELD 12FR SS VENA CAVA FILTER
MDR report key: 673348
·
Received October 28, 2005
Report
- Report Number
- 6000118-2005-00108
- Event Type
- Malfunction
- Date Received
- October 28, 2005
- Date of Event
- September 29, 2005
- Report Date
- September 29, 2005
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DTK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SAME CASE AS MANUFACTURER REPORT# 6000018-2005-00107. DURING A TREATMENT PROCEDURE TO PLACE A GREENFIELD VENA CAVA FILTER, THE FILTER WOULD NOT DEPLOY AFTER BEING ADVANCED TO THE TARGET LOCATION. THE UNDEPLOYED FILTER WAS REMOVED AND REPLACED WITH ANOTHER GREENFIELD FILTER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS `FINE.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENFIELD 12FR SS VENA CAVA FILTER | VENA CAVA FILTERS | DTK | BOSTON SCIENTIFIC | NA | 7602102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |