FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2 EVH SYSTEM
MDR report key: 2012211
·
Received February 1, 2011
Report
- Report Number
- 2242352-2011-00010
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 4, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT, AND THERE WERE NO NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HARVESTER THOUGHT THE CONICAL TIP HAD A CRACK IN IT BECAUSE THERE WAS MOISTURE GETTING INSIDE. 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 HEMOPRO 2 EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 25023505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |