BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 6011744 · Received October 7, 2016

    Report

    Report Number
    3005168196-2016-01432
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 9, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012179
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS KINKED APPROXIMATELY 77.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THE NEURON MAX WAS KINKED. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE NEURON MAX DURING USE, AND LIKELY CONTRIBUTED TO THE INABILITY TO ADVANCE DEVICES THROUGH THE NEURON MAX DURING THE PROCEDURE. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING DEVICES THROUGH THE NEURON MAX; THEREFORE, THE NEURON MAX WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THE NEURON MAX WAS KINKED AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663449 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F69487 00814548012179

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR