BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466P306X

    MDR report key: 6676993 · Received June 29, 2017

    Report

    Report Number
    1016427-2017-00416
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    January 1, 2017
    Report Date
    June 29, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY NAZZAL ET AL, COMPLICATIONS RELATED TO INFERIOR VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE, ANN VASC SURG (2010), 24(4): 480-486; THERE  WERE 2 EVENTS OF POST-INSERTION PULMONARY EMBOLISM (PE) FOR THE TRAPEASE ARM OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457340 466P306X CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS CASHEL 466P306X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening