BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOTOME RX44

    MDR report key: 2801783 · Received October 17, 2012

    Report

    Report Number
    MW5027274
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ERCP PROCEDURE, SMALL PORTION (APPROX 2 MM'S) OF SPHINCTEROTOME FROM BOSTON SCIENTIFIC AUTOTOME RX44, 20MM, CUT WIRE, BROKE OFF INTO PT'S DUODENUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX44 20MM CUT WIRE KNS BOSTON SCIENTIFIC RX44 15475191

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention