FDA Adverse Event
Injury
Summary report: N
VNUS CLOSURE FAST CATHETER
MDR report key: 838671
·
Received April 12, 2007
Report
- Report Number
- 2953189-2007-00007
- Event Type
- Injury
- Date Received
- April 12, 2007
- Date of Event
- March 12, 2007
- Report Date
- April 11, 2007
- Manufacturer
- VNUS MEDICAL TECHNOLOGIES, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION WAS REPORTED. THE PRODUCT WAS NOT RETURNED.
Description of Event or Problem · 1
ANTERIOR LATERAL TRIBUTARY TREATED. FIRST POST-OPERATION DUPLEX. THROMBUS PROTRUDING INTO COMMON FEMORAL VEIN. NOT CLASSIFYING AS A DEEP VEIN THROMBUS. LOVENOX GIVEN TO PREVENT PROPAGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNUS CLOSURE FAST CATHETER | INTRAVASCULAR CATHETER | GEI | VNUS MEDICAL TECHNOLOGIES, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |