BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 10332247 · Received July 28, 2020

    Report

    Report Number
    3005168196-2020-01032
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 5, 2020
    Report Date
    July 5, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT ILIAC ARTERIES USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CATD AND SHEATH. WHILE INSERTING THE CATD INTO THE SHEATH FOR THE FOURTH PASS, THE TIP OF THE CATD KINKED. THE PHYSICIAN THEN ATTEMPTED TO RESOLVE THE KINK; HOWEVER, IT THEN OVALIZED AS WELL AT THE ANGLE OF THE CATD. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN 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
    799352 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. CATD-C H10104 00815948020481

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR