BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 6106197 · Received November 16, 2016

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    Report

    Report Number
    3005168196-2016-01625
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THE INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) WAS KINKED. THE KINKED CAT6 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756090 INDIGO SYSTEM ASPIRATION CATHETER 6 DXE DXE PENUMBRA, INC. F68835 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1