BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU PATH BIOPSY NEEDLE

    MDR report key: 805685 · Received January 12, 2007

    Report

    Report Number
    6000043-2007-00004
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    December 11, 2006
    Report Date
    December 18, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET IT'S SPECIFICATIONS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE: A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    DURING A PROCEDURE OF A TRANS RECTAL ULTRASOUND PROSTATE BIOPSY THAT OCCURRED IN 2006, DIFFICULTY OCCURRED WHEN THE PHYSICIAN POSITIONED THE NEEDLE AT THE PROSTATE AND FIRED THE NEEDLE SUCCESSFULLY INTO THE PROSTATE, BUT THE SECOND FIRING MECHANISM FAILED TO FIRE, AND THEREFORE,SECURE THE BIOPSY SAMPLE INSIDE IT'S SHEATH. BECAUSE OF THIS THE SHEATH DID NOT FIRE, AND THE EXPOSED BIOPSY NEEDLE BECAME CAUGHT ON THE PROSTATE TISSUE. THE PHYSICIAN ATTEMPTED TO MANEUVER THE NEEDLE FREE, BUT WAS FORCED TO "TEAR" THE NEEDLE FREE OF THE PROSTATE TISSUE. THE PATIENT SUFFERED ADDITIONAL BLEEDING TO WHAT IS NORMALLY EXPECTED DURING THIS PROCEDURE. THE PATIENT IS IN SATISFACTORY CONDITION. THIS PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU PATH BIOPSY NEEDLE BIOPSY DEVICE (FCG) FCG BOSTON SCIENTIFIC M0065001151 9075279

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other