BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 10984772 · Received December 10, 2020

    Report

    Report Number
    3005168196-2020-02236
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 17, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AND K161523.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA INTRODUCER SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE CATD INTO THE INTRODUCER SHEATH USING A PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE TIP OF THE CATD KINKED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND THE SAME INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452351 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. F91146

    Patients

    Seq Age Sex Outcome Treatment
    1