BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1812221 · Received August 18, 2010

    Report

    Report Number
    MW5017155
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ERCP. BRUSH CYTOLOGY WAS TAKEN FROM THE COMMON HEPATIC DUCT AND THEN, A SECOND ONE FROM THE DISTAL COMMON BILE DUCT. DURING THE BRUSH CYTOLOGIES, A RING OF RADIOPAQUE PAINT MATERIAL BECAME DISLODGED FROM THE CATHETER AND POSITIONED ITSELF AT THE LEVEL OF THE HILUM. A PROLONGED EFFORT ENSUED USING A VARIETY OF DEVICES TO EXTRACT THIS RING OF RADIOPAQUE PAINT MATERIAL. THE EXTRACTION EFFORT EXCEEDED THE ENTIRE EFFORT TO PERFORM THE ERCP. BALLOON DILATIONS WERE PERFORMED OF THE PROXIMAL AND DISTAL EXTRAHEPATIC BILE DUCT USING A 4-MM HYDROSTATIC DILATING BALLOON. IT WAS POSSIBLE TO PULL AN 11.5-MM BALLOON FROM THE HILUM OUT TO THE DUODENUM SUBSEQUENT TO THE BALLOON DILATIONS. THIS EFFORT DID NOT HELP IN THE EXTRACTION OF THE FOREIGN BODY EITHER. THE PROCEDURE WAS FINALLY TERMINATED ANTICIPATING THAT DUE TO THE PATENCY OF THE EXTRAHEPATIC BILIARY TREE, IT MAY LIKELY FLOW OUT OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC RX WIRE GUIDED CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC CORPORATION M00545000 13391434
    2 BOSTON SCIENTIFIC RX WIRE GUIDED CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC CORPORATION 13329565
    3 BOSTON SCIENTIFIC RX WIRE GUIDED CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC CORPORATION 13048067

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention