BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 12

    MDR report key: 11809552 · Received May 11, 2021

    Report

    Report Number
    3005168196-2021-01016
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 17, 2021
    Report Date
    April 17, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K200771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CAT12 CONFIRMED A FRACTURE AT THE HUB BENEATH THE ID BAND. IF THE DEVICE IS MISHANDLED AT EXTREME ANGLES DURING USE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. FURTHER EVALUATION REVEALED BENDS ALONG THE DEVICE. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT. PENUMBRA CATHETERS ARE 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN AND VENA CAVA USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, AFTER SUCCESSFUL REMOVAL OF THE CLOT IN THE LEFT ILIAC AND VENA CAVA, THE PHYSICIAN WENT UP AND OVER TO TAKE THE CLOT OUT OF THE RIGHT. WHEN THE PHYSICIAN GRABBED THE CAT12 OUTSIDE OF THE PATIENT TO START ON THE RIGHT SIDE, THE CAT12 BROKE AT THE HUB. THEREFORE, THE CAT12 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705529 INDIGO SYSTEM LIGHTNING 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ100-A F101963 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1 53