BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 8

    MDR report key: 10841727 · Received November 15, 2020

    Report

    Report Number
    3005168196-2020-02000
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00815948022508
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN (SFV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER INSERTING THE CAT8 INTO THE SHEATH; CONSEQUENTLY, THE MID SHAFT OF THE CAT8 BECAME KINKED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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
    1306771 INDIGO SYSTEM ASPIRATION CATHETER 8 DXE DXE PENUMBRA, INC. CAT8TORQ85KIT-B H10463 00815948022508

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR