BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME

    MDR report key: 919245 · Received March 29, 2007

    Report

    Report Number
    6000048-2007-00111
    Event Type
    Malfunction
    Date Received
    March 29, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAM OF THE DEVICE CONFIRMED THE BROKEN WIRE; SUBSEQUENT MICROSCOPIC EXAM REVEALED BURN MARKS ON BOTH WIRE ENDS. THE PROXIMAL BROKEN END WAS BENT AND HAD A SPHERICAL SHAPED TIP. THE DISTAL BROKEN END WAS ROUNDED AND EXHIBITED A JAGGED TIP. THE PROXIMAL SEGMENT OF THE CUTTING WIRE WAS ACTUATED BY THE CATHETER HANDLE, CONFIRMING CONNECTION BETWEEN THE WIRE AND THE HANDLE. A CALIBRATED MULTIMETER CONFIRMED ELECTRICAL CONDUCTIVITY FROM THE HANDLE TO THE WIRE BREAK. FULL EVALUATION WAS NOT POSSIBLE DUE TO THE CONDITION OF THE CUTTING WIRE. THE ROOT CAUSE OF THE DEVICE MALFUNCTION CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. TWO ADDITIONAL COMPLAINTS WERE REPORTED FOR THE SAME LOT NUMBER, 9121641; SAME ISSUE, SAME CUSTOMER. THE FEBRUARY 2007 PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BSC ON 03/02/2007 THAT DURING AN ERCP WHILE "APPLYING HIGH FREQUENCY CURRENT, THE CUTTING WIRE BROKE". PATIENT IS MALE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND DEVICE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME KNS KNS BOSTON SCIENTIFIC M00583040 9121641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR