BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 10727416 · Received October 23, 2020

    Report

    Report Number
    3005168196-2020-01814
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 29, 2020
    Report Date
    September 29, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K200771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED LIGHTNING WAS UNABLE TO CONFIRM THE REPORTED EVENT. THERE WAS NO DAMAGED ON THE RETURNED DEVICE. DURING FUNCTIONAL TESTING, THE AUDIO AND VISUAL CUES FUNCTIONED AS INTENDED. THE REPORTED SOLID RED LIGHT COULD NOT BE RECREATED; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. PENUMBRA LIGHTNING UNITS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT FEMORAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE LIGHTNING INDICATOR LIGHT TURNED A SOLID RED DURING THE MIDDLE OF THE PROCEDURE WHILE THE PHYSICIAN ADVANCED THE CAT12 OVER A GUIDEWIRE THROUGH A TORTUOUS SEGMENT THAT TOOK APPROXIMATELY TEN MINUTES UNDER ASPIRATION. DURING THIS TIME, NO BLOOD WAS OBSERVED INSIDE THE LIGHTNING. AN ATTEMPT WAS MADE TO FLUSH THE LIGHTNING GENTLY USING A 30ML SYRINGE; HOWEVER, THE INDICATOR LIGHT REMAINED RED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING 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
    1195353 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ100-A F99617 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR