BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1011861 · Received March 11, 2008

    Report

    Report Number
    3005099803-2008-00228
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: NOT LABELED. A VISUAL EXAM OF THE RETURNED DEVICE CONFIRMED THAT THE EXPOSED CUTTING WIRE AND ANCHOR NOTCH APPEARS BLACKENED, AND HAD SEPARATED FROM THE EXTRUSION. THE DISTAL END OF THE EXTRUSION APPEARED MELTED AND DISCOLORED (SEE FIG 1, PG 3). THIS INDICATED THAT EXCESSIVE ELECTRICAL CURRENT FLOWED THROUGH THE DEVICE. THE CAUSE OF THE EXCESSIVE ELECTRICAL CURRENT IS UNK, ALTHOUGH POSSIBLE CAUSES INCLUDE: IMPROPER TOME POSITION ALLOWED THE CUTTING WIRE TO CONTACT THE ENDOSCOPE, WHICH RESULTED IN A SHORT CIRCUIT, AND EXCESSIVE POWER APPLIED TO THE CUTTING WIRE DUE TO IMPROPER GENERATOR SETTINGS. A REVIEW OF THE COMPLAINT DATABASE IDENTIFIED TWO ADD'L SIMILAR COMPLAINTS FOR THIS LOT, FROM THE SAME CUSTOMER. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. THE JANUARY 2008 15-MO JAGTOME SPHINCTEROTOME PROD FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; AND A NEGATIVE TREND HAS BEEN OBSERVED; THEREFORE, AN INVESTIGATION HAS BEEN INITIATED. THE HYDRATOME RX SPHINCTEROTOME PROD FAMILY IS INCLUDED IN THE SAME TREND REPORT AS THE JAGTOME PROD FAMILY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-00229 FOR A DESCRIPTION OF THE SECOND EVENT. A HYDRATOME RX SPHINCTEROTOME WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON A MALE PATIENT (WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE CUTTING WIRE ON THE SPHINCTEROTOME CAME OFF..."THE PHYSICIAN CONTINUED THE PROCEDURE WITH A SECOND HYDRATOME RX SPHINCTEROTOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11340698

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR