BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 2033401 · Received March 22, 2011

    Report

    Report Number
    2133936-2011-00008
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR ANALYSIS. THE LOCATION BALLOON WAS INFLATED WITH 10CC'S OF WATER. UPON VISUAL INSPECTION, WATER WAS OBSERVED LEAKING FROM THE HANDLE AREA WHERE THE EXTRUSION AND THE STRAIN RELIEF MEET. THE DEVICE HISTORY RECORD FOR THE CATHETER WAS REVIEWED; ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICE MET SPECIFICATIONS AT THE TIME OF RELEASE. IN ADDITION, THE LOCATION BALLOON WAS TESTED IN ACCORDANCE WITH APPROVED PROTOCOL BEFORE BEING INSERTED INTO THE PT; NO ISSUES WERE DETECTED DURING TESTING. THE LOCATION BALLOON WOULD NOT REMAIN INFLATED DUE TO THE LEAK IN THE HANDLE PORTION OF THE DEVICE. HOWEVER, THE ROOT CAUSE OF THE LEAK IN THE HANDLE REMAINS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LOCATION BALLOON WOULD NOT REMAIN INFLATED DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE PHYSICIAN INSERTED THE CATHETER W/O ANY ISSUES. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE LOCATION BALLOON WITH STERILE WATER, WATER WAS OBSERVED LEAKING THROUGH THE CATHETER HANDLE. THE LOCATION BALLOON WAS ALSO TESTED IN ACCORDANCE WITH APPROVED PROTOCOL BEFORE BEING INSERTED INTO THE PT; NO ISSUES WERE DETECTED DURING TESTING. THE LOCATION BALLOON MALFUNCTION OCCURRED PRIOR TO ENERGY DELIVERY TO THE CATHETER. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 101103MHA1

    Patients

    Seq Age Sex Outcome Treatment
    1