BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 12054713 · Received June 23, 2021

    Report

    Report Number
    3005168196-2021-01405
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 23, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022560
    PMA / PMN Number
    K202821
    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 LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT12 OVER THE GUIDEWIRE TO THE TARGET VESSEL AND INITIATED ASPIRATION. SUBSEQUENTLY, IT WAS NOTICED THAT THE ROTATING HEMOSTASIS VALVE (RHV) WOULD NOT TIGHTEN ON THE CAT12 AND THAT AIR WAS LEAKING THROUGH THE RHV. THEREFORE, THE RHV WAS REMOVED. IT WAS REPORTED THAT AN ATTEMPT TO ASPIRATE CLOT USING A SMALLER RHV WAS MADE; HOWEVER, THE ASPIRATED CLOT BECAME STUCK IN THE RHV. THEREFORE, THIS RHV WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME LIGHTNING AND CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947590 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12XTORQ100-A F103786 00815948022560

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR