FDA Adverse Event
Injury
Summary report: N
COOK CELECT FEMORAL VENA CAVA FILTER SET
MDR report key: 1231589
·
Received November 14, 2008
Report
- Report Number
- 3002808486-2008-00021
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 17, 2008
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K061815
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION - STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
DURING FILTER PLACEMENT ON A PT FEMORAL IN 2008, THE PHYSICIAN WAS READY TO PLACE THE FILTER VIA FEMORAL APPROACH. WHEN HE WENT TO UNSHEATHE THE FILTER, THE LEGS DID NOT DEPLOY. (3002808486/2008/00020). THE PHYSICIAN RETRIEVED BOTH FILTERS VIA JUGULAR APPROACH AND THEN DEPLOYED A TULIP IVC JUGULAR FILTER FOR THE PATIENT. THE PATIENT OUTCOME IS FINE. THE FILTER WAS BEING PLACED DUE TO A SCHEDULED GASTRIC BYPASS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK CELECT FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E221576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |