BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1599852 · Received February 4, 2010

    Report

    Report Number
    2133936-2010-00003
    Event Type
    Injury
    Date Received
    February 4, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 4, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS IS AVAILABLE. THE TREATMENT FILE FROM THE CONTROL UNIT WAS OBTAINED AND ANALYZED BY ENGINEERING. RESULTS OF THE ANALYSIS CONFIRM THAT THE CONTROL UNIT OPERATED PROPERLY BUT SUGGEST THAT THE CATHETER MAY HAVE MIGRATED INTO THE BLADDER APPROXIMATELY 13 MINUTES INTO TREATMENT. THERE IS NO EVIDENCE DOCUMENTING THAT THE CATHETER POSITION WAS VERIFIED THROUGHOUT THE TREATMENT. THE CATHETER DEVICE HISTORY RECORD WAS OBTAINED AND 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. 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 (TUMT) PROCEDURE, THE PHYSICIAN CONFIRMED HIS PATIENT HAD DEVELOPED A RECTAL FISTULA. THE PHYSICIAN SUCCESSFULLY COMPLETED THE TUMT PROCEDURE WITH A UROLOGIX COOLWAVE CONTROL UNIT AND A CTC ADVANCE SHORT MICROWAVE TREATMENT CATHETER. APPROXIMATELY 3 WEEKS AFTER THE TREATMENT, THE PATIENT COMPLAINED OF URINE COMING THROUGH HIS RECTUM AND UPON EXAMINATION BY THE PHYSICIAN, IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED A FISTULA AT THE BLADDER NECK. THE PATIENT WAS TREATED WITH A SUPRAPUBIC CATHETER AND DIVERTING COLOSTOMY. NO FURTHER 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. 5000A 091112MHA1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other