FDA Adverse Event
Malfunction
Summary report: N
TRAPEASE PERMANENT VENA CAVA FILTER
MDR report key: 1031361
·
Received April 17, 2008
Report
- Report Number
- 9610978-2008-00101
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- DQO
- PMA / PMN Number
- K020316
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A TRAPEASE FILTER WAS INSERTED INTO THE PATIENT AT A HOSPITAL IN MID 2000. THE PHYSICIAN THAT HAS NOW TAKEN OVER THE CARE OF THIS PATIENT HAS NOTICED THAT THE FILTER HAS FRAGMENTED. HE BELIEVES THAT THIS WAS FIRST EVIDENT IN 2006 AND HAS BEEN MONITORING THE PATIENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING AS IT REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAPEASE PERMANENT VENA CAVA FILTER | THROMBECTOMY SYSTEMS - DQO | DQO | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |