BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 9603387 · Received January 17, 2020

    Report

    Report Number
    3005168196-2020-00064
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 26, 2019
    Report Date
    December 26, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CATD THROUGH THE SHEATH, THE PROXIMAL END OF THE CATD KINKED; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD AND ANOTHER NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63959 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F90374

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR