BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUPATH BIOPSY DEVICE

    MDR report key: 1063473 · Received June 20, 2008

    Report

    Report Number
    3005099803-2008-00877
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    PROCEDURE DATE: 2008. THE TRUPATH BIOPSY DEVICE WAS USED IN TRANSRECTAL ULTRASOUND OF THE PROSTATE WITH BIOPSY PROCEDURE. THE TRUPATH WAS INSERTED INTO THE SEPARATE CHAMBER ON THE ULTRASOUND PROBE TO OBTAIN THE BIOPSY. THE PROBE WAS PLACED IN THE RECTUM. THE PROBE WAS CLEANED THOROUGHLY BETWEEN EACH USE. THE PROCEDURE WENT AS EXPECTED. POST PROCEDURE 3 DAYS LATER, THE PATIENT WENT TO EMERGENCY ROOM BECAUSE OF THE HIGH FEVER WITH CHILLS, WEAKNESS AND FREQUENT URINATION. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR POSSIBLE URINARY TRACT INFECTION. IT IS UNKNOWN WHAT MAY HAVE CAUSED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUPATH BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11390214

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization