BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 12

    MDR report key: 23519976 · Received November 11, 2025

    Report

    Report Number
    3005168196-2025-00360
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 10, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K202821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A PHYSICAL DEVICE INVESTIGATION WAS UNABLE TO BE PERFORMED. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). IT WAS REPORTED THE PATIENT WAS ELDERLY AND HAD VERY DISEASED VESSELS. NEAR THE END OF THE PROCEDURE, A VASCULAR INJURY OCCURRED RESULTING IN THE PATIENT TO COUGH UP BLOOD. THE PATIENT BECAME UNSTABLE AND EXPIRED DESPITE RESUSCITATION EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926861 INDIGO SYSTEM ASPIRATION CATHETER 12 QEW QEW PENUMBRA, INC. C00018613

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death