BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2000705 · Received February 8, 2011

    Report

    Report Number
    2242352-2011-00034
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 10, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, A PLUME OF SMOKE CAME FROM THE TUNNEL WHEN THE VASOVIEW HEMOPRO2 WAS BEING USED. THERE WAS QUITE A BIT OF BLOOD, WHICH WAS REPORTED AS MORE THAN NORMAL. HOWEVER, THE HARVESTER, WHO IS HIGHLY EXPERIENCED, WAS NOT SURE IF THE BLEEDING WAS FROM NICKING SOMETHING OR BURNING TISSUE, SO THERE WAS POSSIBLE USER ERROR. THE HARVESTER WAS COMPLAINING ABOUT SMOKE NOT THE EQUIPMENT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. THERE WERE NO OTHER PT EFFECTS REPORTED. THE LOT NUMBER IS UNK, AS 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other