BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11979562 · Received June 10, 2021

    Report

    Report Number
    3005168196-2021-01311
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022560
    PMA / PMN Number
    K192981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ILIAC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A SEP12 THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND COULD NOT ADVANCE THE SEP12. THEY THEN LOOSENED THE RHV. THE RHV CAP CAME OFF, AND THE O RING FELL OUT. THEY COULD NOT PUT THE O RING BACK INTO PLACE NOR REATTACH THE RHV CAP. WHEN THEY WERE ABLE TO, THE CAT12 WAS LEAKING AIR. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12 AND SAME SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872050 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12XTORQ100-A F103016 00815948022560

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR