BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 12595579 · Received October 7, 2021

    Report

    Report Number
    3005168196-2021-02219
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 12, 2021
    Report Date
    October 7, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 TIBIOPERONEAL TRUNK USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CATRX. WHILE ADVANCING THE CATRX THROUGH A STENTED PORTION OF THE VESSEL DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED AND BROKE THE CATRX INTO THREE PIECES. THEREFORE, THE PHYSICIAN REMOVED THE BROKEN CATRX DIRECTLY FROM THE PATIENT VIA OPEN SURGERY. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485286 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F97413 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention