BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11734463 · Received April 27, 2021

    Report

    Report Number
    3005168196-2021-00883
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2020
    Report Date
    March 31, 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 INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, WHILE LOOSENING THE ROTATING HEMOSTASIS VALVE (RHV) TO CHANGE THE DIRECTION OF PRESSURE, THE BACKEND OF THE RHV CAME APART AND COULD NOT BE PUT BACK INTO POSITION. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630895 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12XTORQ100-A F102249 00815948022560

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR