BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11930608 · Received June 3, 2021

    Report

    Report Number
    3005168196-2021-01230
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 31, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022577
    PMA / PMN Number
    K210323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2021-01230 1. SECTION G. BOX 5. 510 (K). EVALUATION OF THE RETURNED RHV CONFIRMED THAT THE ROTOR CAP WAS DETACHED FROM THE HOUSING. IF THE RHV IS LOOSENED BEYOND ITS LIMITS OR IS OTHERWISE FORCEFULLY MISHANDLED DURING USE, DAMAGE SUCH AS A ROTOR CAP DETACHMENT MAY OCCUR. DURING THE FUNCTIONAL TEST, THE RHV WAS REASSEMBLED AND WAS UNABLE TO FUNCTION 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. H3 OTHER TEXT: PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. 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 IN THE INFERIOR VENA CAVA (IVC) USING A ROTATING HEMOSTASIS VALVE (RHV) PACKAGED WITH THE LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE SEP12 WAS BEING REMOVED OUT FROM THE RHV MULTIPLE TIMES AND, CONSEQUENTLY, THE BACK OF THE RHV POPPED OFF AND WAS UNABLE TO BE SEALED AGAIN. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME LIGHTNING, CAT12, AND SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825308 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ115-A F103892 00815948022577

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR