BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB

    MDR report key: 3919106 · Received June 16, 2014

    Report

    Report Number
    2242352-2014-00686
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS OBSERVED THAT THE PATIENT HAD BURN MARKS ON THE SKIN. THE BURN WAS TREATED WITH ORAL ANTIBIOTIC AND A TOPICAL SKIN CREAM. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING FINE. THE SALES REP NOTED THAT THE HOSPITAL HAD STATED THAT IT WAS THE HARVESTER'S TECHNIQUE THAT CAUSED THE BURN MARK AND NOT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352505 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3200

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other