BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11304839 · Received February 9, 2021

    Report

    Report Number
    3005168196-2021-00246
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 15, 2021
    Report Date
    January 15, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022577
    PMA / PMN Number
    K200771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 ILIAC VEIN AND THE SUPERFICIAL FEMORAL VEIN (SFV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RE-INTRODUCE AN INDIGO SYSTEM SEPARATOR 12 (SEP12) THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AFTER MULTIPLE ATTEMPTS WERE MADE. IT WAS REPORTED THAT WHILE ATTEMPTING TO INTRODUCE THE SEP12 THROUGH THE RHV, THE PATIENT SUFFERED EXCESSIVE BLOOD LOSS. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV, THE SAME CAT12, AND THE SAME SEP12. NO OTHER EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199605 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ115-A F100355 00815948022577

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR