BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 4120686 · Received August 29, 2014

    Report

    Report Number
    4120686
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING THE PULMONARY PROCEDURE WHEN DEVICE WAS BEING USED IN AN OFF-LABEL MANNER, THE CUTTING BALLOON STARTED LEAKING AND AN ATHEROTOME (LONGITUDINAL BLADE) DETACHED FROM IT. IT WAS RETRIEVED USING AN ENDOSCOPIC GRASPER. THE DOCTOR WROTE IN HIS NOTES, "BALLOON DILATION TO 6MM PERFORMED OF RIGHT MIDDLE LOBE. NO SIGNIFICANT BLEEDING AND DILATION OF RML NOT SIGNIFICANT POST INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528168 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY LIT BOSTON SCIENTIFIC CORPORATION * 16964400

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO OTHER THERAPIES| BRONCHOSCOPE