BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY CORE BIOPSY SYSTEMS

    MDR report key: 1193214 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02942
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER THE DEVICE WAS INSERTED INTO TARGET LESION UNDER ECHO, IT WAS FIRED TO CATCH TISSUE. THE AREA BEING BIOPSIED WAS LOCATED IN THE MEDIASTINUM. HOWEVER, AT FIRST USE, THE NEEDLE BECAME BENT. AFTER THE FIRST USE, THE PHYSICIAN USED THE DEVICE AGAIN AFTER FIXING THE BEND NEEDLE BY HAND. TOTALLY TWO CATCHES WITH THIS DEVICE WERE PERFORMED. ACCORDING TO THE PHYSICIAN, IT MAY BE POSSIBLE THAT THE NEEDLE HIT THE BONE OF THE PATIENT DURING THE FIRST FIRING. THE BEND WAS FOUND AT THE NOTCH PROXIMAL OF THE INNER NEEDLE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CORE BIOPSY SYSTEMS FCG KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC CORPORATION M001434531 11388644

    Patients

    Seq Age Sex Outcome Treatment
    1