BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE FX

    MDR report key: 3021288 · Received March 22, 2013

    Report

    Report Number
    3021288
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    March 22, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS DEPLOYED SUCCESSFULLY BUT AS THE PHYSICIAN BEGAN TO TORQUE THE DEVICE TO SECURE IT-THE HANDLE TO THE TORQUING MECHANISM BROKE OFF IN THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ASD CLOSURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120789 AMPLATZER TORQVUE FX CATHETER, PERCUTANEOUS, ANTERIOR SEPTAL DEFECT CLOSURE DQY ST. JUDE MEDICAL 9-ITVFX08545/80 1212112615

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES