BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 11741883 · Received April 28, 2021

    Report

    Report Number
    3005168196-2021-00899
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2020
    Report Date
    April 1, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CIRCUMFLEX ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATRX WITH RESISTANCE TO THE TARGET VESSEL AND COMPLETED ONE PASS. SUBSEQUENTLY, WHILE ATTEMPTING TO INITIATE ASPIRATION USING THE CATRX TO MAKE THE NEXT PASS, THE PHYSICIAN NOTICED BLOOD TO BE LEAKING OUT AND THE MIDSHAFT OF THE CATRX TO BE KINKED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING BALLOONS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636100 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F99613 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR