BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 3805650 · Received May 12, 2014

    Report

    Report Number
    2133936-2014-00002
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 12, 2014
    Manufacturer
    UROLOGIX, INC
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL LOCATION BALLOON FAILURE REPORTED, A FOLLOW-UP CALL WAS PLACED WITH THE UROLOGIX APPLICATION SPECIALIST TO OBTAIN ADDITIONAL DESCRIPTION OF THE FAILURE. THE APPLICATION SPECIALIST STATED THAT HE HAD TO KEEP FILLING THE COOLANT BAG THROUGHOUT THE TREATMENT BECAUSE OF COOLANT LEAKING FROM A HOLE IN THE HANDLE. HE CLARIFIED THAT IT WAS NOT THE LOCATING BALLOON. HE FURTHER DESCRIBED THAT THE COOLANT BAG DRAINED REPEATEDLY AND HE KEPT REFILLING IT. THE DR. HAD HIM CHANGE OUT THE CATHETER AND THE TREATMENT WAS COMPLETED. THE TAG INDICATED LOW COOLANT ERRORS AND 11 MINUTES OF TREATMENT TIME. COOLANT WAS RUN THROUGH THE CATHETER AND THE COOLANT LEAKED FROM A HOLE IN THE HANDLE. FAILURE ANALYSIS INCLUDED VISUAL INSPECTION AND EVALUATION OF THE DYE FILL, RESECTION OF THE LOCATION BALLOON AND OPENING OF HANDLE VALVES. FAILURE ANALYSIS REVEALED COOLANT LEAKING FROM THE COOLANT INFILL PORT INTO THE LOCATION BALLOON THROUGH THE HANDLE. THE LEAK PATH WAS CREATED BY AN INCOMPLETE ADHESIVE FILL AT THE PROXIMAL-MOST ANNULAR HANDLE FILL. DURING A TREATMENT, THIS HANDLE CROSS-TALK CONDITION MAY HAVE CAUSED THE LOCATION BALLOON TO OVERFILL AND RUPTURE, LEADING TO A LOW PRESSURE ERROR. ALTHOUGH THIS FAILURE MODE MAY HAVE CAUSED A RUPTURE IN THE LOCATION BALLOON, THE SYSTEM PRESSURE MONITOR WILL SENSE THIS CONDITION AND CEASE MICROWAVE DELIVERY ALMOST IMMEDIATELY. THEREFORE, PATIENT INJURY IS UNLIKELY TO OCCUR AS A RESULT OF THIS CONDITION.

    Description of Event or Problem · 1

    DURING TREATMENT, HOLES IN BALLOON INFLATION PORT BECAME EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283818 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC 410092-001 121113MCA2

    Patients

    Seq Age Sex Outcome Treatment
    1