BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA IV PEV.2,30MM ACTIVE TRANSFER DEVICE

    MDR report key: 372178 · Received January 16, 2002

    Report

    Report Number
    1062385-2002-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 16, 2002
    Manufacturer
    NOVOSTE CORPORATION
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT THEY EXPERIENCED WATER LEAKAGE WHILE ATTEMPTING TO SEND THE SEEDS, THEY BELIEVED THE SEEDS WERE RETURNED TO THE TRANSFER DEVICE, THEY DISCONNECTED THE CATHETER, THEN REALIZED THAT THE SEEDS WERE NOT ALL CONTAINED WITHIN THE BETA-CATH SYSTEM. NOVOSTE WAS CONTACTED AND ALL OF THE SEEDS WERE EVENTUALLY ACCOUNTED FOR. THE DEVICE WILL BE RETURNED TO NOVOSTE FOR EVAL. COMPLAINANT REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED, THERE WAS NO MISADMINISTRATION, AND NO NEGATIVE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA IV PEV.2,30MM ACTIVE TRANSFER DEVICE TRANSFER DEVICE MOU NOVOSTE CORPORATION A1732 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *