BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 2254867 · Received September 8, 2011

    Report

    Report Number
    2133936-2011-00013
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 10, 2011
    Report Date
    September 7, 2011
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED A LARGE TEAR IN THE LOCATION BALLOON. 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 PT'S ANATOMY AND THE PRESENCE OF THE BLADDER STONE MOST LIKELY CAUSED THE TEAR IN THE LOCATION BALLOON.

    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, THE BALLOON DEFLATED AND NO RESISTANCE COULD BE FELT. UPON REMOVAL OF THE CATHETER, THE LOCATION BALLOON WAS TESTED AND THE LEAK IN THE BALLOON WAS CONFIRMED. 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 DEFLATED PRIOR TO ENERGY DELIVERY TO THE CATHETER. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PHYSICIAN ATTEMPTED TO INSERT A SECOND CATHETER BUT WAS UNSUCCESSFUL. A CYSTOSCOPY WAS PERFORMED AND A SMALL BLADDER STONE WAS DETECTED. THE TREATMENT WAS RESCHEDULED; HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO INSERT THE CATHETER DURING THE SECOND ATTEMPT TO TREAT THE PT. THE CATHETER WOULD NOT PASS THROUGH THE BLADDER NECK DUE TO THE PT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. TH1321C 110706MHA2

    Patients

    Seq Age Sex Outcome Treatment
    1