BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN

    MDR report key: 3013293 · Received March 20, 2013

    Report

    Report Number
    1220452-2013-00018
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE REPORTED EVENT INDICATED THAT THE DEVICE DID NOT FAIL TO PERFORM AND FUNCTIONED PROPERLY, THEREFORE REVIEW OF THE DEVICE HISTORY RECORD WAS NOT CONDUCTED. THE EVENT HAS NOT BEEN CONFIRMED. NO MALFUNCTION INDICATED FOR THE EVENT. THE ANALYSIS IS COMPLETE AS OF (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN DEVICE PROBLEM. THE ACTUAL DEVICE USED DURING THE CASE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED. DEVICE DISCARDED - NOT RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CAS WAS UNDERGONE TO RIGHT CAROTID ARTERY. TEMPORARY OCCLUSION DEVICE WAS USED FOR DISTAL PROTECTION. OCCLUSION TIME WAS 16 MINUTES AND THE BALLOON WAS INFLATED TO 4.5MM DURING PRE-DILATATION, STENTING AND POST-DILATION PROCEDURE. ASYMPTOMATIC HYPER PERFUSION SYNDROME WAS NOTED BY BRAIN BLOOD FLOW SPECT TEST AFTER CAS OPERATION. A 30 DAYS FOLLOW-UP WAS CONDUCTED. PHYSICIAN IS DETERMINED THAT THIS IS NOT AN ADVERSE EVENT. ADDITIONAL INFORMATION INDICATES THAT THERE WAS NO DEVICE PROBLEM AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115515 GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC NFA MEDTORNIC, INC 0006526091

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR