BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 12733964 · Received November 1, 2021

    Report

    Report Number
    3005168196-2021-02447
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 1, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022577
    PMA / PMN Number
    K210323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A NON-PENUMBRA DIAGNOSTIC CATHETER, A NON-PENUMBRA SHEATH, AND GLIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO ADVANCE THE DIAGNOSTIC CATHETER OVER THE GLIDEWIRE AND INTO THE TARGET VESSEL. AFTERWARDS, WHILE ATTEMPTING TO MAKE THE FIRST PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE CAT12 OVER A GLIDEWIRE AND INTO THE TARGET LOCATION. THEREFORE, THE CAT12 AND LIGHTNING WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ENDOVASCULAR SYSTEM. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629492 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ115-A F103658 00815948022577

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR