BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTE

    MDR report key: 439360 · Received January 21, 2003

    Report

    Report Number
    MW1027312
    Event Type
    Malfunction
    Date Received
    January 21, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 14, 2003
    Manufacturer
    NOVOSTE CORP
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    SR-90 RADIATION SOURCES COULD NOT RETURN TO TRANSFER DEVICE AFTER AN "IVBT" CASE. SOURCES "STUCK" NEAR HUB. CATHETER AND SOURCES WERE REMOVED FROM PATIENT AND PLACED IN ACRYLIC BOX. TRANSFER DEVICE, CATHETER WITH SOURCES SENT BACK TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOSTE SR-90 BETA-CATH SYSTEM MOU NOVOSTE CORP 5F 40MM SOURCE TRAIN RADIATION SOURCE TRAIN #186/01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR