BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 10525737 · Received September 11, 2020

    Report

    Report Number
    3005168196-2020-01466
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00815948020481
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523. 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 TO TREAT AN ARTERIOVENOUS (AV) FISTULA GRAFT USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), A GUIDEWIRE AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD OVER THE GUIDEWIRE THROUGH THE SHEATH FROM THE BRACHIAL ARTERY TO THE AV GRAFT AND ATTEMPTED TO PERFORM ASPIRATION USING THE CATD. HOWEVER, AFTER FIVE MINUTES, THE CATD WAS NOT ASPIRATING, AND THE PHYSICIAN REALIZED THE DISTAL END OF THE CATD WAS KINKED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD 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
    988754 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. CATD-C H10288 00815948020481

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR