BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 11290003 · Received February 5, 2021

    Report

    Report Number
    3005168196-2021-00233
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 6, 2021
    Report Date
    July 20, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE FROM THE HOSPITAL FOR INVESTIGATION WERE UNSUCCESSFUL. THEREFORE, 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). UPON COMPLETION OF THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE NEURON MAX TO BE REMOVED. SUBSEQUENTLY, AFTER RETRACTING APPROXIMATELY TEN CENTIMETERS OF THE NEURON MAX OUT FROM THE PATIENT, THE NEURON MAX BECAME KINKED AND BROKEN. CONSEQUENTLY, THE COIL WIND AND THE OTHER 70 CENTIMETERS OF THE NEURON MAX REMAINED IN THE PATIENT WITH THE TIP OF THE NEURON MAX IN THE DISTAL V2 SEGMENT. THEREFORE, THE PHYSICIAN PERFORMED A RADIAL ARTERY CUTDOWN SURGERY TO REMOVE THE BROKEN PIECE OF THE NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184912 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention