BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM CAT8 ASPIRATION CATHETER

    MDR report key: 5089625 · Received September 18, 2015

    Report

    Report Number
    3005168196-2015-00888
    Event Type
    Death
    Date Received
    September 18, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 13, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016290
    PMA / PMN Number
    K142870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). THE PHYSICIAN SUCCESSFULLY REMOVED THE THROMBUS BY USING THE CAT8. 45 MINUTES FOLLOWING THE PROCEDURE, THE PATIENT EXPIRED. THE RELATIONSHIP OF THE CAT8 TO THE PATIENT'S DEATH IS UNKNOWN AND THE PHYSICIAN IS UNCERTAIN ABOUT THE SPECIFIC CAUSE OF THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619226 INDIGO SYSTEM CAT8 ASPIRATION CATHETER DXE DXE PENUMBRA, INC. 00814548016290

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death