BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC PINNACLE SHEATH

    MDR report key: 689769 · Received March 13, 2006

    Report

    Report Number
    689769
    Event Type
    Death
    Date Received
    March 13, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 23, 2006
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE CONNECTION OF THE FLUSH BAG TO THE 3 WAY LUER LOCK OF THE SHEATH, THE FLUSH BAG WAS FOUND DISCONNECTED RESULTING IN HEMORRHAGE RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC PINNACLE SHEATH 6F SHEATH (PINNACLE) DYB TERUMO MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death