BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAINAGE SET

    MDR report key: 518309 · Received March 30, 2004

    Report

    Report Number
    1820334-2004-00170
    Event Type
    Other
    Date Received
    March 30, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 2, 2004
    Manufacturer
    COOK INCORPORATED
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO ADVANCE THE WIRE GUIDE TO THE COMMON BILE DUCT, THE WIRE GUIDE HEADED TO A PERIPHERY OF THE BILE DUCT. THE PHYSICIAN MANIPULATED THE WIRE GUIDE AND UPON WITHDRAWAL, NOTED THE TOP HAD SEVERED FROM THE WIRE GUIDE AND LEFT IN THE BILE DUCT. NO RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPTED WITHDRAWAL. THE PHYSICIAN JUDGED THE SEVERED TIP WOULD NOT OBSTRUCT ALLEVIATION OF JAUNDICE, AND THAT AN ADDITIONAL PROCEDURE WOULD INCUR GREATER RISK, THEREFORE, IT WAS DECIDED NOT TO RETRIEVE THE SEVERED TIP. THE PT'S FAMILY WAS INFORMED OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET DRAINAGE SET FGE COOK INCORPORATED NA F1441555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other