BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE REMOVAL DEVICE

    MDR report key: 1052755 · Received May 23, 2008

    Report

    Report Number
    3005099803-2008-00540
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED BY THE COMPLAINANT; THEREFORE, AN EVAL CANNOT BE PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED; NO ANOMALIES WERE NOTED RELATED TO THIS EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RECORDED FOR THE LOT. THE APRIL 2008 15-MONTH PRODUCT FAMILY COMPLIANT TREND REPORT INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME STONE REMOVAL DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PROCEDURE ABOUT 3 DAYS PRIOR (FEMALE PT, AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, "... THE CUTTING WIRE BROKE WHEN [THE PHYSICIAN] WENT TO PERFORM THE SPHINCTEROTOMY." THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE, WITH A SECOND STONETOME STONE REMOVAL DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT, AND THE PT WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME STONE REMOVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535110 11124255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK