BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 10897844 · Received November 24, 2020

    Report

    Report Number
    3005168196-2020-02090
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    October 29, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K200771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED LIGHTNING COULD NOT CONFIRM THE REPORTED COMPLAINT. THE LIGHTNING WAS ABLE TO ASPIRATE FLUID INTO THE DEMONSTRATION CANISTER WITHOUT AN ISSUE. ALL AUDIO AND VISUAL CUES WERE OBSERVED. THE LIGHTNING FUNCTIONED AS INTENDED. PENUMBRA DEVICES ARE VISUALLY 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.

    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 USING IN THE COMMON ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHILE THE LIGHTNING WAS IN THE OFF POSITION, THE PHYSICIAN ADVANCED THE CAT12 OVER A WIRE AND INTO THE INFERIOR VENA CAVA (IVC). SUBSEQUENTLY, THE PHYSICIAN TURNED THE SWITCH ON. IT WAS REPORTED THAT THE INDICATOR LIGHT ON THE LIGHTNING UNIT WAS GREEN. THE LIGHTNING THEN CLICKED SEVERAL TIMES AND THE INDICATOR LIGHT TURNED SOLID RED. THE LIGHTNING WAS UNPLUGGED TWICE FROM THE ENGINE AND RE-PLUGGED, BUT THE INDICATOR LIGHT REMAINED SOLID RED. AT THIS POINT, THE LIGHTNING WAS NOTICED TO BE CLOGGED. THE PHYSICIAN THEN CAREFULLY AND SLOWLY FLUSHED THE LIGHTNING WITH A 3-WAY STOPCOCK AND 60CC SYRINGE; HOWEVER, THE INDICATOR LIGHT REMAINED SOLID 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
    1362650 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ100-A F99569 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR