FDA Adverse Event
Injury
Summary report: N
CORDIS
MDR report key: 2982714
·
Received February 22, 2013
Report
- Report Number
- MW5029158
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 22, 2013
- Manufacturer
- CORDIS
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IVC FILTER WAS UNABLE TO BE DEPLOYED DURING PROCEDURE. UPON INSPECTION, IT WAS FOUND THAT THE FILTER STRUT WAS PROTRUDING THROUGH THE SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77354 | CORDIS | OPTEASE FILTER | DTK | CORDIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |