BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS SYSTEM

    MDR report key: 857655 · Received May 31, 2007

    Report

    Report Number
    2133936-2007-00015
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 31, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR ANALYSIS. THE CATHETER WAS CUT IN HALF, THEREFORE, SIMULATED TREATMENT COULD NOT BE PERFORMED. HOWEVER, UPON DISSECTION OF THE CATHETER IT APPEARS THE DEFLATION LUMEN WAS MELTED. THE DEVICE HISTORY RECORD WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. DISSECTION OF THE CATHETER REVEALED THAT THE DEFLATION LUMEN WAS MELTED, HOWEVER, BECAUSE SIMULATED TREATMENT COULD NOT BE PERFORMED, THE ROOT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUCCESSFUL TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE LOCATION BALLOON WAS UNABLE TO BE DEFLATED. AFTER ATTEMPTING TO DEFLATE WITH A SYRINGE THE NURSE CALLED TECH SUPPORT FOR FURTHER INSTRUCTIONS. TECH SUPPORT EXPLAINED TO THE NURSE TO CUT THE LUER LOCK HOSE, HOWEVER, DEFLATION WAS STILL UNSUCCESSFUL. TECH SUPPORT THEN EXPLAINED TO THE NURSE TO CUT THE SHAFT OF THE CATHETER, HOWEVER, AGAIN DEFLATION WAS UNSUCCESSFUL. THE LOCATION BALLOON WAS SUCCESSFULLY DEFLATED WITH AN ULTRASOUND GUIDED NEEDLE. NO FURTHER PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT STATUS IS REPORTED AS "WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A 070205MC3

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention