BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 4240933 · Received November 4, 2014

    Report

    Report Number
    2242352-2014-01196
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SILICONE ON THE VASO VIEW HEMOPRO CAME APART AND FELL INTO THE PATIENT'S LEG. AN EXTRA INCISION WAS MADE IN THE LOWER LEG TO STOP THE BLEEDING AND TO REMOVE THE PIECE FROM THE PATIENT'S LEG. THE LAST PASSAGE IN LOWER LEG THE WIRE DIVIDED THE VEIN IN HALF. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT'S CONDITION WAS NOT EFFECTED. THE DIVIDED VEIN WAS TAKEN OUT IN TWO PIECES, TRIMMED WHERE IT HAD ACCIDENTALLY BEEN CAUTERIZED AND USED FOR TWO DIFFERENT BYPASS GRAFTS. BLOOD LOSS WAS ESTIMATED AT 4CC AND NO TRANSFUSION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706597 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25102414

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other