BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHNEIDER (VASCULAR LINES)

    MDR report key: 2894704 · Received July 11, 2008

    Report

    Report Number
    2894704
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    March 7, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MOF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHEATH OVER THE GUIDEWIRE DID NOT MAKE IT AROUND A VESSEL CORNER AND PIERCED THE PT'S ATRIUM. SURGERY PERFORMED AND PT TRANSFERRED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHNEIDER (VASCULAR LINES) GUIDEWIRE MOF BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention