BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS OCCLUSION DEVICE-JAPAN

    MDR report key: 1982391 · Received January 14, 2011

    Report

    Report Number
    1220452-2011-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 17, 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

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE OCCLUSION BALLOON WIRE REVEALED EVIDENCE OF DRIED BLOOD INDICATING USE. VISUAL EXAMINATION OF THE OCCLUSION BALLOON MATERIAL REVEALED THAT THE MATERIAL IS TORN AWAY FROM THE PROXIMAL SEAL BAND AND FOLDED IN A DISTAL DIRECTION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MANUFACTURING PROCESS. THE EVENT HAS BEEN CONFIRMED FOR DEFLATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE OCCLUSION BALLOON DEFLATED UNEXPECTEDLY. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PATIENT AND INFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL. THE OCCLUSION BALLOON THEN DEFLATED UNEXPECTEDLY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE TO COMPLETE THE CASE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS OCCLUSION DEVICE-JAPAN NFA MEDTRONIC, INC. NA 0004529654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA