BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1731207 · Received June 17, 2010

    Report

    Report Number
    2133936-2010-00011
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 17, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS WAS CONDUCTED. THE TREATMENT FILE FROM THE TARGIS CONTROL UNIT WAS OBTAINED AND ANALYZED BY ENGINEERING. RESULTS OF THE ANALYSIS CONFIRM THAT THE CONTROL UNIT OPERATED PROPERLY. THE CATHETER AND RTU DEVICE HISTORY RECORDS WERE REVIEWED; ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES, AND THE DEVICES MET SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS RETURNED FOR ANALYSIS, AND THE TREATMENT FILE DEMONSTRATES THE CONTROL UNIT OPERATED APPROPRIATELY, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH SIGNIFICANT BLEEDING AND WAS HOSPITALIZED AFTER THE ADMINISTRATION OF AMICAR. THE PHYSICIAN COMPLETED THE PROCEDURE ON (B) (6) 2010 WITH A TARGIS CONTROL UNIT AND A CTC ADVANCE SHORT (2.5-3.5) MICROWAVE TREATMENT CATHETER AND STATED THAT THE PATIENT TOLERATED THE TREATMENT WELL AT THE TIME. THE PHYSICIAN PERFORMED A CYSTOSCOPY ON THE PATIENT SHORTLY AFTER THE TUMT PROCEDURE AND DESCRIBED THE PROSTATE AS APPEARING TO HAVE A SMALL SURFACE BURN TO THE RIGHT SIDE AND SMALL CHUNKS OF TISSUE BEING SLOUGHED OFF WITH BLOOD PRESENT; THE AREA WAS LIKE A "TURP LIKE EFFECT BUT NOT EXACTLY". AS OF (B) (6) 2010, THE PATIENT HAS ONLY A VERY SMALL TRACE OF BLOOD IN HIS URINE. THE PATIENT IS STILL IN THE HOSPITAL, HOWEVER, THE PHYSICIAN BELIEVES THE PATIENT'S PROSTATE ISSUE IS RESOLVED AND THAT THE PATIENT REMAINS HOSPITALIZED FOR ISSUES SEPARATE FROM THE TUMT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 100316MHA1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other