FDA Adverse Event
Injury
Summary report: N
VASOVIEW HEMOPRO 2 EVH SYSTEM
MDR report key: 2010874
·
Received March 3, 2011
Report
- Report Number
- 2242352-2011-00113
- Event Type
- Injury
- Date Received
- March 3, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 2, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K101274
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE OPERATING ROOM STAFF NOTICED BUBBLES ON THE LEFT SIDE OF THE HEART. THE PROCEDURE WAS OFF-PUMP UNTIL THIS WAS NOTICED, AND THEN WENT TO ON-PUMP. IT WAS REPORTED THAT "EVH WAS USED" BUT IT WAS NOT CLEAR WHETHER IT WAS CAUSED BY THE EVH METHOD. PT EFFECTS ARE UNK. IT IS UNK WHY THE PRODUCT IS NOT RETURNING.
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 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |