FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 6 EVH SYSTEM
MDR report key: 2161658
·
Received June 13, 2011
Report
- Report Number
- 2242352-2010-04101
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- December 29, 2010
- Report Date
- December 30, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE NO EVAL COULD BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-2000 CO2 ONE-WAY VALVE WAS NOT ALLOWING A SEAL INTO PT. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW 6 EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR | VH-2000 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |