BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 2143666 · Received June 23, 2011

    Report

    Report Number
    2143666
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    February 28, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MAQUET
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEARTSTRING III PROXIMAL SEAL SYSTEM WAS FOUND TO BE SLIGHTLY UNWOUND PRIOR TO USE ON THE PATIENT. A SECOND DEVICE WAS OPENED AND USED WITHOUT INCIDENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM CLAMPLESS HEMOSTASIS DEVICE DXC MAQUET * 25025949

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR