BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1200089 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05282
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY OF THE PAPILLA OF VATER THE HYDRATOME RX SPHINCTEROTOME CUTTING WIRE BROKE. THE PHYSICIAN PUT THE TIP OF THE SPHINCTEROTOME INSIDE THE PAPILLA OF VATER. WHEN THE PHYSICIAN PULLED THE HANDLE TO OPEN THE CUTTING WIRE AND APPLIED CURRENT TO CUT THE PAPILLA OPEN, THE CUTTING WIRE BROKE INTO TWO PIECES, HOWEVER, THE CUTTING WIRE WAS STILL ATTACHED TO THE CATHETER. NO PIECE OF THE CUTTING-WIRE FELL OFF INSIDE THE PATIENT. ALL DEVICE BROKEN PIECES COULD BE EASILY REMOVED WITHOUT ANY PATIENT COMPLICATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583050 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR