BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 448210 · Received March 11, 2003

    Report

    Report Number
    1062385-2003-00004
    Event Type
    Other
    Date Received
    March 11, 2003
    Report Date
    March 11, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT AFTER A CASE WHERE THE PATIENT WAS TREATED ON A MID-CIRCUMFLEX INSTENT RESTENOSIS, A DISSECTION WAS NOTED AT THE PROXIMAL PORTION OF THE CIRCUMFLEX. THE CIRCUMFLEX HAD AN ACCUTE ANGLE. THE COMPLAINANT REPORTED THAT THE VESSEL LOOKED GREAT AFTER STENTING THE DISSECTION AND THAT THE PATIENT IS STABLE AND HAD NO SIGNS OF ENZYME INCREASE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. P00563 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization