BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 939817 · Received April 18, 2007

    Report

    Report Number
    2133936-2007-00010
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    January 25, 2006
    Report Date
    April 18, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COOLED THERMOCATH (CTS) WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION A LARGE TEAR WAS CONFIRMED. THE BALLOON WAS INFLATED WITH 10 CC OF AMBIENT WATER. UPON INFLATION, A LEAK WAS CONFIRMED. THE DEVICE HISTORY RECORD FOR THIS WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. IT IS NOTED THAT, THE LABELING REQUIRES THAT THE LOCATION BALLOON BE CHECKED PRIOR TO USE, AFTER INSERTION AT THE BLADDER NECK AND EVERY 5-10 MINUTES DURING TREATMENT. THE LEAK WAS CONFIRMED, HOWEVER, THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, A BALLOON LEAK OCCURRED. THE PHYSICIAN INSERTED THE CATHETER AND PRIOR TO TREATMENT, A LEAK WAS NOTICED. THE PHYSICIAN THEN ATTEMPTED TO INSERT ANOTHER CATHETER, HOWEVER, WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED. NO PATIENT 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 050908MC2

    Patients

    Seq Age Sex Outcome Treatment
    1 *