BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE WEB EXTRACTION BASKET

    MDR report key: 482322 · Received September 8, 2003

    Report

    Report Number
    1037905-2003-00069
    Event Type
    Death
    Date Received
    September 8, 2003
    Date of Event
    July 26, 2003
    Report Date
    August 7, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ERCP, THE PHYSICIAN USED A WILSON-COOK WEB EXTRACTION BASKET TO FACILITATE REMOVAL OF A BILIARY STONE. EXTRACTION OF THE STONE WAS UNSUCCESSFUL. A MECHANICAL LITHROTRIPSY WAS ATTEMPTED, BUT TO NO AVAIL. THE DRIVE WIRES OF THE BASKET BROKE. PRIOR TO SURGERY TO FACILITATE REMOVAL OF THE DEVICE, THE PT WENT INTO CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE WEB EXTRACTION BASKET EXTRACTION BASKETS FFL WILSON-COOK MEDICAL, INC. NA 1686714

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R