BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 3632981 · Received February 18, 2014

    Report

    Report Number
    2133936-2014-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 18, 2014
    Manufacturer
    UROLOGIX, INC
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE: FAILURE OF THE LOCATION BALLOON DISTAL ADHESIVE JOINT, ALLOWING THE COUDE TIP TO BECOME DISLODGED AND THE LOCATION BALLOON TO BLEED OUT THROUGH THE COUDE TIP AND DEFLATE. ROOT CAUSE: COMMUNICATION BETWEEN THE COOLANT INFLOW AND LOCATION BALLOON PARTITIONS OF THE PLASTIC HANDLE. DURING TREATMENT, THE PUMP FORCED FLUID INTO THE LOCATION BALLOON UNTIL IT BUILT UP ENOUGH PRESSURE TO BLOW THE DISTAL ADHESIVE JOINT. ADDITIONALLY, THE COMPLAINT STATED THAT A LOW PRESSURE ERROR WAS GENERATED APPROXIMATELY 10 MINUTES INTO THE PROCEDURE. THE BALLOON FAILURE LIKELY DID NOT OCCUR UNTIL SHORTLY BEFORE THE LOW PRESSURE ERROR OCCURRED. AT THE RATE THAT THE COOLANT WAS "LEAKING" INTO THE LOCATION BALLOON, IT WOULD HAVE ONLY TAKEN 1-2 MINUTES FROM THE TIME OF THE ADHESIVE JOINT FAILURE FOR THE FLUID TO DRAIN OUT OF THE SYSTEM (THUS GENERATING THE LOW PRESSURE ERROR.)

    Description of Event or Problem · 1

    FIELD SERVICE WAS CONTACTED BY A UROLOGIX TSR AFTER HE REPORTED RECEIVING A LOW PRESSURE ERROR APPROXIMATELY 10 MINUTES INTO A CTT PROCEDURE. THE TSR SAID THAT THE COOLANT BAG WAS EMPTY AND HE ATTEMPTED TO CONTINUE THE PROCEDURE AND WHILE CHECKING THE LOCATION BALLOON, NO WATER COULD BE DRAWN OUT FROM THE LOCATION BALLOON FILL PORT. AT THAT POINT, THE PROCEDURE WAS STOPPED, THE CATHETER WAS REMOVED. THE TSR STATED THAT IT APPEARED AS THOUGH THE LOCATION BALLOON HAD FAILED. THE MICROWAVE POWER WAS BEING OPERATED AT APPROXIMATELY 30 WATTS DURING THE PROCEDURE. THE TSR SAID THE CATHETER DID NOT MIGRATE BECAUSE IT WAS BEING HELD IN POSITION BY THE MDS HOLDER, SO NO PATIENT INJURY HAD OCCURRED. THE CATHETER WAS CHANGED AND THE CTT PROCEDURE WAS CONTINUING WITHOUT ANY ADDITIONAL ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102819 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC 410092-001 130815MCA2

    Patients

    Seq Age Sex Outcome Treatment
    1