BEUDAMED
    FDA Adverse Event Summary report: N

    NOVOSTE

    MDR report key: 442013 · Received January 21, 2003

    Report

    Report Number
    442013
    Date Received
    January 21, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 14, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    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