BEUDAMED
    FDA Adverse Event Death Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 484645 · Received September 18, 2003

    Report

    Report Number
    1062385-2003-00012
    Event Type
    Death
    Date Received
    September 18, 2003
    Date of Event
    August 18, 2003
    Report Date
    September 18, 2003
    Manufacturer
    NOVOSTE CORP
    Product Code
    MOU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEATH. COMPLAINANT REPORTED THAT ANGIOMAX WAS USED WITH VASCULAR BRADYTHERAPY TREATMENT. COMPLAINANT REPORTED THAT THE PT WAS TREATED FOR TWO RADIATION SEGMENTS FOR A TOTAL OF 7 MINUTE TREATMENT TIME. PT DEVELOPED A THROMBUS FORMATION IMMEDIATELY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP ABR-0340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death