FDA Adverse Event
Injury
Summary report: N
VNUS CLOSURE FAST CATHETER
MDR report key: 852642
·
Received May 17, 2007
Report
- Report Number
- 2953189-2007-00008
- Event Type
- Injury
- Date Received
- May 17, 2007
- Date of Event
- April 17, 2007
- Report Date
- May 10, 2007
- Manufacturer
- VNUS MEDICAL TECHNOLOGIES, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION WAS REPORTED. THE PRODUCT WAS NOT RETURNED.
Description of Event or Problem · 1
PATIENT UNDERWENT RF ABLATION PROCEDURE IN 2007. A DEEP VEIN THROMBUS EXTENSION WAS DETECTED IN THE LEFT GREATER SAPHENOUS VEIN UPON 48-HOUR PATIENT FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNUS CLOSURE FAST CATHETER | INTRAVASCULAR CATHETER | GEI | VNUS MEDICAL TECHNOLOGIES, INC. | CF7-7-60 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |