BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 8332473 · Received February 12, 2019

    Report

    Report Number
    3005168196-2019-00245
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 14, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017624
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBERS THAT ALSO APPLY TO THIS COMPLAINT: K160533; K161523. 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.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124015 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. F81159 00814548017624

    Patients

    Seq Age Sex Outcome Treatment
    1