BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB

    MDR report key: 4337813 · Received December 10, 2014

    Report

    Report Number
    2242352-2014-01346
    Event Type
    Injury
    Date Received
    December 10, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    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 COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THEY SPLICED THE VESSEL USING THE VASOVIEW 7 XB AND THE SAPHENOUS VEIN WAS BURNED. THEY TRANSECTED OUT THE BURNED AREA AND RECONNECTED THE VEIN. THE PATIENT IS DOING FINE AND IT WAS REPORTED THAT ONLY THE VESSEL WAS BURNED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CHIEF PA NOTED THAT IT WAS OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797492 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVEST GEI MAQUET CARDIOVASCULAR, LLC VH-3200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other