BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS RX-JAPAN

    MDR report key: 1872193 · Received October 12, 2010

    Report

    Report Number
    1220452-2010-00067
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 27, 2010
    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

    RESULTS, CONCLUSION: OTHER: THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE OCCLUSION BALLOON WIRE WAS ENGAGED IN A BALLOON CATHETER. THE EXTENSION WIRE WAS MISSING FROM THE OCCLUSION BALLOON WIRE. THE OCCLUSION BALLOON MATERIAL WAS BAGGY AND CLOUDY (INDICATING THAT THE OCCLUSION BALLOON HAD BEEN INFLATED AT ONE POINT). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MFG PROCESS. THE EVENT HAS BEEN CONFIRMED FOR DEFLATION, THE EXTENSION WIRE WAS PULLED OUT OF THE OCCLUSION BALLOON WIRE RESULTING IN DEFLATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE OCCLUSION BALLOON DEFLATED. DURING THE PROCEDURE, THE OCCLUSION BALLOON WIRE BECAME SEPARATED FROM THE ADAPTOR AND THE OCCLUSION BALLOON DEFLATED. PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS RX-JAPAN NFA MEDTRONIC INC. NA 0001731714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA