BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPATH BIOPSY DEVICE

    MDR report key: 1230351 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06142
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (NEEDLE TIP BROKE). INFO WAS COMPLETED BY THE MANUFACTURER BASED ON INFO OBTAINED FROM THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROSTATE BIOPSY USING A TRUPATH BIOPSY DEVICE, THE TIP OF THE BIOPSY NEEDLE BROKE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PT IS REPORTED TO BE "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUPATH BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11921397

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR