BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA-CATH 3.5F SYSTEM

    MDR report key: 4384678 · Received December 23, 2014

    Report

    Report Number
    4384678
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 23, 2014
    Manufacturer
    BEST VASCULAR, INC.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE BETA-CATH PROCEDURE (VASCULAR BRACHYTHERAPY), THE RADIOACTIVE STRONTIUM-90 SOURCE WAS NOT RETRACTED TO THE SAFE POSITION DUE TO THE CATHETER KINK AT THE END OF THE TREATMENT. THE WHOLE TREATMENT WAS DONE WITHOUT ANY DISCREPANCY BETWEEN PRESCRIBED AND DELIVERED DOSE. THE SOURCE WAS MANUALLY PLACED IN THE SHIELDED CONTAINER, AND CURRENTLY IS IN THE SHIELDED ROOM (HOT LAB). THE SOURCE IS ADDITIONALLY SHIELDED AND IT WILL BE SHIPPED TO THE VENDOR WHEN WE RECEIVE THE PROPER SHIELDING CONTAINER FROM THE VENDOR. THE MANUFACTURER IS SENDING A REPRESENTATIVE TO INSPECT THE DEVICE AND DETERMINE WHETHER THE SOURCES MAY BE SAFELY RETRACTED. THESE KINKS ARE KNOWN WITHIN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847347 BETA-CATH 3.5F SYSTEM INTRAVASCULAR RADIATION DELIVERY SYSTEM MOU BEST VASCULAR, INC. * 84025

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR