BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANSFIELD EP BOSTON SCIENTIFIC CORPORATION

    MDR report key: 227737 · Received June 16, 1999

    Report

    Report Number
    MW1016548
    Event Type
    Injury
    Date Received
    June 16, 1999
    Date of Event
    June 3, 1999
    Report Date
    June 8, 1999
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WITH ADVANCEMENT OF SHEATH INTO RIGHT FEMORAL VEIN, TIP SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANSFIELD EP BOSTON SCIENTIFIC CORPORATION HEMOSTASIS INTRODUCER SHEATH DYB BOSTON SCIENTIFIC CORP. 5643 F50359

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention