BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEST VASCULAR INC NOVOSTE B-RAIL DELIVERY CATH

    MDR report key: 11912477 · Received May 28, 2021

    Report

    Report Number
    MW5101623
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BEST VASCULAR INC
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS USED TO DELIVER RADIATION FOR BRACHYTHERAPY. UPON INSPECTION OF THE DEVICE FOLLOWING THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE CATHETER WAS MISSING AND HAD BECOME DETACHED IN THE PATIENT'S BLOOD VESSEL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801327 BEST VASCULAR INC NOVOSTE B-RAIL DELIVERY CATH INTRAVASCULAR RADIATION DELIVERY SYSTEM MOU BEST VASCULAR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention