BEUDAMED
    FDA Adverse Event Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 448110 · Received March 11, 2003

    Report

    Report Number
    1062385-2003-00003
    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

    THE COMPLAINANT REPORTED THAT THE PT WAS TREATED WITH BALLOON ANGIOPLASTY THEN WITH BRACHYTHERAPY. FOLLOWING THE BRACHYTHERAPY PROCEDURE, THE CARDIOLOGIST NOTED A DISSECTION FROM THE PROXIMAL PORTION OF THE ARTERY TO THE DISTAL AND REFERRED THE PT TO BYPASS SURGERY. THE PT STATUS IS STABLE.

    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