BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME XL SPHINCTEROTOME

    MDR report key: 910196 · Received September 12, 2007

    Report

    Report Number
    6000048-2007-00281
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Report Date
    August 15, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    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 COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVAL. A DEVICE ANALYSIS WILL NOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THIS DEVICE AND THE REPORTED EVENT IS UNK. A CUSTOMER SHIPMENT HISTORY WAS REVIEWED AND IDENTIFIED THE THREE MOST RECENT LOTS SHIPPED TO THE CUSTOMER PRIOR TO THE RECEIPT OF THE COMPLAINT AS POSSIBLE LOTS FOR THE SUSPECT DEVICE: 9802866, 9731975, AND 9785046. THE DEVICE HISTORY RECORD FOR EACH OF THESE LOTS WAS REVIEWED; NO ISSUES OR DISCREPANCIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS REPORTED FOR THE SAME THREE LOTS. THE JULY 2007 15-MONTH ULTRATOME XL SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. SEE ASSOCIATED MEDWATCH #6000048-2007-00280.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. THIS REPORT PERTAINS TO THE SECOND OF TWO MALFUNCTIONS OCCURRING IN THE SAME PROCEDURE. IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME SPHINCTEROTOME WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGEOANCREATOGRAPHY PROCEDURE (PT GENDER, AGE, AND WEIGHT UNK). ACCORDING TO THE COMPLAINT, THE "CUT WIRE ON THE ULTRATOME SNAPPED." THE PHYSICIAN REPORTEDLY REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A SECOND ULTRATOME SPHINCTEROTOME DEVICE. THE PT DID NOT SUSTAIN ANY COMPLICATIONS OR ILL EFFECTS DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME XL SPHINCTEROTOME FDI BOSTON SCIENTIFIC CORP. M00535900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR