BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN

    MDR report key: 3424688 · Received October 23, 2013

    Report

    Report Number
    1220452-2013-00056
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (CONCLUSION NOT YET AVAILABLE: EVALUATION IN PROGRESS). CONCLUSION: CONCLUSION NOT YET AVAILABLE: EVALUATION IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THE GUARDWIRE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE DEVICE WAS PREPPED AS PER IFU AND NO DIFFICULTIES WERE RECORDED IN CARRYING OUT PREPARATION. PHYSICIAN ADVANCED THE RELEVANT DEVICE (GUARDWIRE) INTO ICA, AND INFLATED THE BALLOON TO OCCLUDE THE VESSEL. NO RESISTANCE WAS FELT WHEN ADVANCING THE GUIDEWIRE. THE BALLOON WAS UNEXPECTEDLY DEFLATED BEFORE HE INSERTED THE BALLOON FOR PRE-DILATATION. THE OCCLUSION BALLOON WAS INFLATED TWICE BEFORE THE FAILURE OCCURRED, TEST INFLATION IN VITRO AND 1ST INFLATION IN VIVO. HE STOPPED THE USE AND COMPLETED THE OPERATION PROCEDURE WITH OTHER GDW PROTECTION SYSTEM. NO HEALTH HAZARD WAS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544447 GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC NFA MEDTRONIC, INC 0006837477

    Patients

    Seq Age Sex Outcome Treatment
    1