BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB EVH SHORT PORT

    MDR report key: 1881263 · Received October 6, 2010

    Report

    Report Number
    2242352-2010-03025
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A DEVICE LOT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD'L INFO IS OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BALLOON ON THE VASOVIEW 7 XB SHORT PORT HAD A HOLE IN IT AND WOULD NOT INFLATE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE LOT NUMBER IS UNK, AS THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB EVH SHORT PORT SHORT PORT GEI MAQUET CARDIOVASCULAR, LLC. VH-3200 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA