BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 5

    MDR report key: 6117776 · Received November 21, 2016

    Report

    Report Number
    3005168196-2016-01658
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE HOSPITAL DISPOSED OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 510K#: K160533

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) BECAME KINKED. IT WAS NOTED THAT THE CAT5 WAS NOT KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKING OF THE CAT5 OCCURRED PRIOR TO INSERTING IT INTO THE SHEATH; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW CAT5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767246 INDIGO SYSTEM ASPIRATION CATHETER 5 DXE DXE PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1