FDA Adverse Event
Other
Summary report: N
CLOSUREFAST CATHETER
MDR report key: 1032479
·
Received April 14, 2008
Report
- Report Number
- 2953189-2008-00004
- Event Type
- Other
- Date Received
- April 14, 2008
- Date of Event
- March 3, 2008
- Report Date
- April 14, 2008
- Manufacturer
- VNUS MEDICAL TECHNOLOGIES
- Product Code
- GEI
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT WAS STILL SYMPTOMATIC AT FIVE WEEKS, BUT IMPROVED SLIGHTLY. IT WAS REPORTED THAT THE PHYSICIAN PRESCRIBED LYRIC TO THE PATIENT. EVALUATION OF THE RETURNED CATHETER CONFIRMED THE PRODUCT MET ALL OF THE MANUFACTURER'S SPECIFICATIONS. EXACT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. IF ANY ADD'L INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PATIENT EXPERIENCED SAPHENOUS NERVE DAMAGE FOLLOWING VENOUS ABLATION THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLOSUREFAST CATHETER | RF VENOUS ABLATION CATHETER | GEI | VNUS MEDICAL TECHNOLOGIES | CF7-7-60 | 342711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |