BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 2151916 · Received July 7, 2011

    Report

    Report Number
    2133936-2011-00010
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 6, 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 DEVICE HISTORY RECORD FOR THE CATHETERS WERE REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICE MET SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE 1 WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED A NEARLY CIRCUMFERENTIAL TEAR IN THE LOCATION BALLOON. DEVICE 2 WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER CONFIRMED A TEAR IN THE LOCATION BALLOON. THE ROOT CAUSE OF THE LOCATION BALLOON TEARS WERE MOST LIKELY DUE TO THE PATIENT'S ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER LOCATION BALLOON LEAKS OCCURRED WITH TWO CTC ADVANCE 4.5+ CATHETERS DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE PHYSICIAN INSERTED THE FIRST CATHETER (DEVICE 1) WITHOUT ANY ISSUES. WHILE PULLING BACK ON THE CATHETER TO POSITION THE LOCATION BALLOON, NO RESISTANCE COULD BE FELT AND THE CATHETER SLID OUT. A SECOND CATHETER (DEVICE 2) WAS INSERTED AND THE SAME INCIDENT OCCURRED; THE CATHETER SLID OUT WHEN THE PHYSICIAN ATTEMPTED TO SEAT THE LOCATION BALLOON. THE PHYSICIAN THEN INSERTED A THIRD CATHETER, WHICH WAS A CTC 3.0-5.0 CATHETER, AND WAS ABLE TO COMPLETE TREATMENT USING THE THIRD CATHETER. BOTH LOCATION BALLOONS ON THE CTC ADVANCE 4.5+ CATHETERS WERE TESTED IN ACCORDANCE WITH APPROVED PROTOCOL BEFORE BEING INSERTED INTO THE PATIENT; NO ISSUES WERE DETECTED DURING TESTING. THE LOCATION BALLOON LEAKS OCCURRED PRIOR TO ENERGY DELIVERY TO THE CATHETER. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PHYSICIAN STATED THAT HE DID NOT KNOW OF ANY PATIENT ANATOMY CONDITIONS AND THOUGHT THAT THE LOCATION BALLOON PROBLEMS WERE CAUSED BY BLADDER SPASMS. FOLLOW UP WITH THE PHYSICIAN POST-TREATMENT REVEALED THAT HE ALSO ATTEMPTED TO PLACE FOUR FOLEY CATHETERS IN THE PATIENT POST-TREATMENT, HOWEVER ALL FOUR FOLEY CATHETER BALLOONS BURST AS WELL. THE PHYSICIAN WAS FINALLY ABLE TO PLACE A HEMATURIA CATHETER BY ONLY INFLATING THE 30CC BALLOON TO 10-15CC WHICH ALLOWED ADDITIONAL FLEXIBILITY IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 410093-001 110209MLA1

    Patients

    Seq Age Sex Outcome Treatment
    1