BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 10400912 · Received August 13, 2020

    Report

    Report Number
    3005580113-2020-00393
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 13, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AS REPORTED TO CUSTOMER RELATIONS: "MALDEPLOYMENT. THE FILTER ENDED UP SIDEWAYS. CUSTOMER DESCRIBED FILTER AS NOT COMPLETELY OPENING UP WHEN IT DEPLOYED. CUSTOMER HAD TO GET SECONDARY ACCESS (JUGULAR) AND PROCEEDED WITH RETRIEVAL. COMPLAINT FILTER ENDED UP UPSIDE DOWN DURING RETRIEVAL. FILTER HAD TO BE RETRIEVED FROM THE GROIN (TERTIARY ACCESS). CUSTOMER PLACED ANOTHER FILTER OF THE SAME GPN TO COMPLETE PROCEDURE WITHOUT INCIDENT." PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866337 COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34502 E3897647 10827002345024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention