BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTING III PROXIMAL SEAL SYSTEM

    MDR report key: 1232823 · Received October 31, 2008

    Report

    Report Number
    1232823
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    GUIDANT CARDIOVASCULAR
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE DID NOT DEPLOY. NO INJURY TO PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTING III PROXIMAL SEAL SYSTEM ANASTOMOSIS DEVICE DXC GUIDANT CARDIOVASCULAR 3.8 MM 8092471

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR