BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 4987879 · Received August 5, 2015

    Report

    Report Number
    2242352-2015-00627
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25108181, 25112026 AND 25115922. THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO DEVICE'S CAUTERY DID NOT WORK PROPERLY. THERE WAS MAJOR BLEEDING (THIS WAS THE FIRST BURN), HOWEVER DEVICE WORKED ON ALL THE OTHER BRANCHES. THE PA "DEALT" WITH THE BLEEDING, THE VESSEL RETRACTED AND STOPPED BLEEDING EVENTUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518896 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC C-VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other