FDA Adverse Event
Other
Summary report: N
VNUS CLOSUREFAST CATHETER
MDR report key: 1051306
·
Received May 22, 2008
Report
- Report Number
- 2953189-2008-00007
- Event Type
- Other
- Date Received
- May 22, 2008
- Date of Event
- April 18, 2008
- Report Date
- May 22, 2008
- Manufacturer
- VNUS MEDICAL TECHNOLOGIES, INC.
- Product Code
- GEI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER HAS MADE NUMEROUS ATTEMPTS TO RECEIVE ADDITIONAL INFORMATION WITHOUT SUCCESS. THE CLOSUREFAST CATHETERS WERE NOT RETURNED AND COULD NOT BE EVALUATED. NO LOT OR CATALOG NUMBER INFORMATION IS AVAILABLE. FURTHER INVESTIGATION OF THE REPORTED EVENT CANNOT BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PRACTICE REPORTED TWO INSTANCES OF DEEP VEIN THROMBOSIS AND ONE PULMONARY EMBOLISM FOLLOWING VENOUS ABLATION PROCEDURES. NO OTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNUS CLOSUREFAST CATHETER | RADIO FREQUENCY CATHETER | GEI | VNUS MEDICAL TECHNOLOGIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |