BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 8144390 · Received December 7, 2018

    Report

    Report Number
    3005168196-2018-02391
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) # THAT ALSO APPLIES TO THIS COMPLAINT: K160533; K161523. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) TO TREAT A BILATERAL DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT WAS NOTED THAT THE ANGLE OF ACCESS WAS ACUTE AND DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CATD, THEN NOTICED THAT THE CATD BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984039 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. F83399

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR