BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 485187 · Received September 18, 2003

    Report

    Report Number
    1062385-2003-00011
    Event Type
    Other
    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
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT TOOK APPROXIMATELY 1 MINUTE AFTER THE 4:09 DWELL TREATMENT TIME TO REMOVE THE DELIVERY CATHETER AND THE RADIOACTIVE SOURCE TRAIN FROM THE PATIENT TO THE BAILOUT BOX. PATIENT CONDITION IS CURRENLTY STABLE. THE COMPLAINANT REPORTED THE EVENT TO THE STATE AS A MISADMINISTRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other