BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 10522115 · Received September 11, 2020

    Report

    Report Number
    3005168196-2020-01446
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 18, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00815948020481
    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2020-01447.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATD THROUGH THE SHEATH, THE MID-SHAFT OF THE CATD KINKED. SUBSEQUENTLY, THE CATD WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING THE CATRX AND THE SHEATH. WHILE ADVANCING THE CATRX THROUGH THE SHEATH, THE PROXIMAL END OF THE CATRX KINKED. THEREFORE, THE CATRX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) 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
    987393 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. CATD-C H10187 00815948020481

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR