BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 9453921 · Received December 11, 2019

    Report

    Report Number
    3005168196-2019-02272
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    November 12, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE NEURON MAX SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, VESSEL SPASM, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED COMPLICATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-02271.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT (KIT) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE A PASS, THE PHYSICIAN ADVANCED THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND GLIDEWIRE THROUGH THE NEURON MAX. HOWEVER, AS THE JET7 DISTAL TIP WAS EXITING OUT OF THE NEURON MAX DISTAL TIP IN THE ICA, THE PHYSICIAN NOTICED THE JET7 HAD FOLDED OVER THE NEURON MAX AND BECAME WRAPPED AROUND OFF TO THE SIDE. THEREFORE, THE PHYSICIAN RETRACTED THE NEURON MAX AND SUCCESSFULLY STRAIGHTEN OUT THE JET7. THE PROCEDURE WAS THEN COMPLETED USING THE SAME JET7 AND NEURON MAX RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THERE WAS SPASM IN THE ICA; HOWEVER, IT IS UNKNOWN HOW THE SPASM WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246251 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other