BEUDAMED
    FDA Adverse Event Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 448106 · Received March 11, 2003

    Report

    Report Number
    1062385-2003-00002
    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 A DISTAL DISSECTION OCCURRED DURING DELIVERY OF THE BRACHYTHERAPY BETA-RAIL DELIVERY CATHETER. THE INTERVENTIONAL CARDIOLOGIST INSERTED A STENT FOLLOWING THE BRACHYTHERAPY PHASE OF THE PROCEDURE. NO ADDITIONAL SURGERY WAS REQUIRED. PT CONDITION 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