BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 2254868 · Received September 8, 2011

    Report

    Report Number
    2133936-2011-00014
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 8, 2011
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CATHETER WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED A LARGE TEAR IN THE LOCATION BALLOON. ALTHOUGH THE LOCATION BALLOON LEAK WAS CONFIRMED, THE CAUSE OF THE LEAK REMAINS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER LOCATION BALLOON LEAK OCCURRED DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE PHYSICIAN INSERTED THE CATHETER WITHOUT ANY ISSUES. WHILE PULLING BACK ON THE CATHETER TO POSITION THE LOCATION BALLOON, NO RESISTANCE COULD BE FELT AND THE CATHETER SLID OUT. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE LOCATION BALLOON WAS LEAKING. 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 LEAK 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. TF1221C 110128MLA1

    Patients

    Seq Age Sex Outcome Treatment
    1