BEUDAMED
    FDA Adverse Event Death Summary report: N

    3.5 BETA-RAIL DELIVERY CATHETER

    MDR report key: 536598 · Received July 27, 2004

    Report

    Report Number
    1062385-2004-00005
    Event Type
    Death
    Date Received
    July 27, 2004
    Date of Event
    July 23, 2004
    Report Date
    July 26, 2004
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THAT INCLUDED THE BETA-RAIL DELIVERY CATHETER, THERE WAS A DISSECTION. PT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5 BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. P02561 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death