BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 12232352 · Received July 27, 2021

    Report

    Report Number
    3005168196-2021-01671
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 2, 2021
    Report Date
    August 12, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022577
    PMA / PMN Number
    K210323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE FIRST RETURNED LIGHTNING CONFIRMED A SOLID RED LIGHT. EVALUATION REVEALED THE PRESSURE SENSOR IN THE SWITCH WAS NOT FULLY CONNECTED TO THE HOUSING. THE LIGHTNING WAS UNABLE TO ASPIRATE WATER INTO THE CANISTER. AFTER PROPERLY RE-SEATING THE PRESSURE SENSOR CONNECTOR, AND THE UNIT FUNCTIONED AS INTENDED. EVALUATION OF THE SECOND RETURNED LIGHTNING CONFIRMED A SOLID RED LIGHT. EVALUATION REVEALED THE PRESSURE SENSOR IN THE SWITCH WAS NOT FULLY CONNECTED TO THE HOUSING. THE LIGHTNING WAS UNABLE TO ASPIRATE WATER INTO THE CANISTER. AFTER PROPERLY RE-SEATING THE PRESSURE SENSOR CONNECTOR, AND THE UNIT 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2021-01672.

    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01672.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL AND SUPERFICIAL FEMORAL VEIN (SFV) TO THE COMMON FEMORAL USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT IMMEDIATELY TURNED SOLID RED AFTER PLUGGING INTO THE ENGINE. THE PHYSICIAN UNPLUGGED AND PLUGGED THE LIGHTNING UNIT MULTIPLE TIMES TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE ENGINE WAS REMOVED AND REPLACED WITH ANOTHER ENGINE, BUT THE INDICATOR LIGHT ON THE LIGHTNING UNIT REMAINED SOLID RED WHEN PLUGGED INTO THE SECOND ENGINE. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN OPENED A NEW LIGHTNING KIT AND PLUGGED IN THE LIGHTNING UNIT INTO THE ENGINE; HOWEVER, THE INDICATOR LIGHT FOR THE LIGHTNING UNIT TURNED SOLID RED AS WELL. THE LIGHTNING UNIT WAS THEREFORE, REMOVED. THE PROCEDURE WAS COMPLETED USING THE ASPIRATION TUBING (TUBING) FROM AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WITH THE SAME CAT12 FROM THE FIRST LIGHTNING KIT AND THE FIRST ENGINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. IT WAS ALSO REPORTED AFTER THE PROCEDURE WAS COMPLETED, A PENUMBRA SALES REPRESENTATIVE TESTED THE SECOND ENGINE WITH A DEMO LIGHTNING AND WAS ABLE TO ACHIEVE ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132394 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ115-A F103998 00815948022577

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR