BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 8279686 · Received January 25, 2019

    Report

    Report Number
    3005168196-2019-00159
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    December 30, 2018
    Report Date
    January 2, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-00160.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE AXILLARY ARTERY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE CATD UP TO THE CLOT, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE CATD BECAME KINKED; THEREFORE, THE CATD WAS REMOVED. THE PHYSICIAN OPENED A NEW CATD; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE CATD AND ADMINISTERED THROMBOLYTICS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71684 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F82871

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR