BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 9112125 · Received September 24, 2019

    Report

    Report Number
    3005168196-2019-01804
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 28, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017624
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 SUBCLAVIAN VEIN USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD THROUGH A NON-PENUMBRA SHEATH AND OVER A GUIDEWIRE. WHILE ADVANCING THE CATD THROUGH A TORTUOUS TIGHT AREA OF THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL END OF THE CATD KINKED; THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD AND THE SAME SHEATH AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903436 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F81034 00814548017624

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR