BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7XB EVH SYSTEM

    MDR report key: 2010809 · Received March 2, 2011

    Report

    Report Number
    2242352-2011-00110
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TIP WAS SPARKING AND MELTED THE BLACK END PIECE WHILE INSIDE THE PATIENT'S LEG. THE SURGEON CONVERTED TO OPEN LEG TO COMPLETE THE PROCEDURE. HE STATED THAT HE CONVERTED BECAUSE IT WAS A "TOUGH LEG" NOT DUE TO THE DEVICE MALFUNCTION. THERE WERE NO PATIENT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25018371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other