BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11942280 · Received June 4, 2021

    Report

    Report Number
    3005168196-2021-01257
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K202821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, AS THE PHYSICIAN WAS USING THE CAT12 FOR ASPIRATION, THEY UNSCREWED THE ROTATING HEMOSTASIS VALVE (RHV), AND THE RHV SUBSEQUENTLY BROKE. IT WAS REPORTED THE CAT12 WAS LEAKING BLOOD AND WOULD NOT ACCEPT A SEPARATOR. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND 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
    837936 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ100-A F103015 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1