BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1001242 · Received February 22, 2008

    Report

    Report Number
    3005099803-2008-00204
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. ALTHOUGH THE CAUSE OF THE EVENT IS UNK, POSSIBLE CAUSES FOR CUTTING WIRE BREAKAGE 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. SINCE THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED BY THE USER, A REVIEW OF THE CUSTOMER'S SHIPMENT HISTORY WAS PERFORMED. THREE LOTS SHIPPED TO THE CUSTOMER PRIOR TO THIS EVENT WERE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THESE LOTS REVEALED NO ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADD'L COMPLAINTS RECORDED FOR THESE LOTS. THE DECEMBER 2007 15-MONTH STONETOME SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. A STONETOME STONE REMOVAL DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON A MALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, "A [SECOND DEVICE] WAS USED TO FINISH THE SPHINCTEROTOMY AND THE CUT WIRE BROKE." THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THIS DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PT WAS REPORTED TO BE "OK" FOLLOWING THE PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT. #3005099803-2008-00203 FOR A DESCRIPTION OF THE FIRST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR