BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 12043052 · Received June 22, 2021

    Report

    Report Number
    3005168196-2021-01391
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 22, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 RIGHT CORONARY ARTERY (RCA) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA GUIDING CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CATRX OVER THE GUIDEWIRE AND THROUGH THE ROTATING HEMOSTASIS VALVE (RHV), THE GUIDEWIRE LUMEN BECAME PUNCTURED ABOUT HALFWAY THROUGH. THE PHYSICIAN THEN RETRACTED THE CATRX AND RE-ATTEMPTED TO ADVANCE THE GUIDEWIRE; HOWEVER, THE MAIN LUMEN OF THE CATRX BECAME PUNCTURED BY THE GUIDEWIRE. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME RHV, A NON-PENUMBRA CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940974 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F103293 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR