BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 10602814 · Received September 29, 2020

    Report

    Report Number
    3005168196-2020-01602
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 2, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). AFTER COMPLETION OF THE PROCEDURE, THE PATIENT HAD ACUTE DELIRIUM, OR CONTRAST INDUCED ENCEPHALOPATHY, AND MILD HYPOTENSIVE ENCEPHALOPATHY, SHOWING UP AS EXPRESSIVE APHASIA. BLOOD PRESSURE WAS ALLOWED TO NORMALIZE AND THE SYMPTOMS RESOLVED. NO FINDINGS WERE NOTED ON THE COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE CONTRAST INDUCED ENCEPHALOPATHY WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE CATRX AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065454 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F96905 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other