BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 10682819 · Received October 15, 2020

    Report

    Report Number
    3005168196-2020-01727
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 21, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K200771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 SUPERFICIAL FEMORAL VEIN (SFV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS SMALL. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE CAT12 UP THE LEG, BUT THE CAT12 WOULD NOT ADVANCE. SUBSEQUENTLY, THE CAT12 WAS REMOVED AND FLUSHED. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE CAT12, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE CAT12 WAS REMOVED AGAIN. THE PROCEDURE WAS COMPLETED BY STENTING AND BALLOONING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149314 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ100-A F98380 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR