BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE STC18 MICROCATHETER

    MDR report key: 12294340 · Received August 6, 2021

    Report

    Report Number
    MW5103094
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FULL DOSE OF Y-90 TREATMENT WAS NOT ADMINISTERED AS THE PRODUCT WAS STUCK IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188775 RENEGADE STC18 MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION GTIN 150 X 30 M00118140 26937614

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR