BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN

    MDR report key: 2883703 · Received December 21, 2012

    Report

    Report Number
    1220452-2012-00074
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTORNIC, INC
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)., METHOD, RESULTS AND CONCLUSIONS: ACTUAL DEVICE USED IN CASE WAS EVALUATED. VISUAL EXAMINATION PERFORMED. THE ACTUAL DEVICE USED IN THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE OCCLUSION BALLOON WIRE REVEALED THAT THE WIRE WAS CUT SOMEWHERE DISTAL TO THE OCCLUSION BALLOON. THE OCCLUSION BALLOON MATERIAL WAS BAGGY AND CLOUDY INDICATING USE, THERE WAS RESIDUAL CONTRAST MEDIA LEFT IN THE BALLOON. THE CUT PIECE OF THE OCCLUSION BALLOON WIRE WITH THE PLUG WAS NOT RETURNED FOR EVALUATION. TEST INFLATION WAS PERFORMED USING AN IN-HOUSE COMPONENTS AND THE OCCLUSION BALLOON WAS ABLE TO BE INFLATED AND DEFLATED SUCCESSFULLY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2012.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE BALLOON WOULD NOT DEFLATE WHEN REQUIRED DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON INTO THE PATIENT AND INFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL. AT SOME POINT DURING THE PROCEDURE THE PHYSICIAN ATTEMPTED TO DEFLATE THE OCCLUSION BALLOON; HOWEVER, IT WOULD NOT DEFLATE. THE PHYSICIAN USED THE METHOD REFERENCED WITHIN THE INSTRUCTION FOR USE AND CUT THE OCCLUSION BALLOON WIRE AND SUCCESSFULLY DEFLATED THE OCCLUSION BALLOON. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE TEMPORARY OCCLUSION SYSTEM - JAPAN DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC NFA MEDTORNIC, INC 0006501036

    Patients

    Seq Age Sex Outcome Treatment
    1