BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM SEPARATOR D

    MDR report key: 7441941 · Received April 18, 2018

    Report

    Report Number
    3005168196-2018-00791
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 23, 2018
    Report Date
    March 23, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017600
    PMA / PMN Number
    K161523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE HOSPITAL DISPOSED OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    PMA: K161523.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE ON THE BACK TABLE, THE INDIGO SYSTEM SEPARATOR D (SEPD) WAS ACCIDENTALLY KNOCKED OFF THE TABLE ONTO THE FLOOR. THE SEPD FELL ON THE FLOOR PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283427 INDIGO SYSTEM SEPARATOR D DXE DXE PENUMBRA, INC. F78736 00814548017600

    Patients

    Seq Age Sex Outcome Treatment
    1