BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE SET

    MDR report key: 604131 · Received May 20, 2005

    Report

    Report Number
    1820334-2005-00162
    Event Type
    Injury
    Date Received
    May 20, 2005
    Date of Event
    March 29, 2005
    Report Date
    April 20, 2005
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING PUNCTURE WITH THE PCHN TO PLACE THE CATHETER IN THE PERIPHERY OF THE BILE DUCT, THE PHYSICIAN INSERTED THE PWG SIRE GUIDE. THE NARROW BILE DUCT HINDERED THE WIRE GUIDE FROM ADVANCING, RESULTING IN THE DEVICE BENDING. THE PHYSICIAN PULLED THE NEEDLE AND THAT THE WIRE GUIDE SLIGHTLY TO EASE THE BAND, WHICH RESULTED IN THE WIRE GUIDE BECOMING STUCK, DURING AN ATTEMPT TO RELEASE THE STUCK WIRE GUIDE, THE COILS OF THE WIRE GUIDE EXTENDED IN WIRE SEPARATION. THE DISTAL PORTION OF THE SEPARATED WIRE GUIDE REMAINED IN THE LIVER, POSSIBLY WITH ONE END OF THE WIRE IN THE PARENCHYMA AND ABDOMINAL CAVITY. THE PROCEDURE WAS STOPPPED WITH PLANS TO REMOVE THE SEPARATED PORTION BY SURGICAL INTERVENTION AT A LATER DATE. THIS ATTEMPTED REMOVAL WAS SUBSEQUENTLY UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET DRAINAGE SET FGE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention