BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 21061309 · Received January 2, 2025

    Report

    Report Number
    3005168196-2024-00430
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 7, 2024
    Report Date
    February 28, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00815948022409
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED NEURON MAX CONFIRMED THAT THE MARKERBAND WAS DETACHED AND REVEALED SIGNIFICANT DISCOLORATION AND DAMAGE TO THE MATERIAL ON THE DISTAL END OF THE CATHETER. THIS TYPE OF DISCOLORATION AND DAMAGE ON THE DISTAL END IS CONSISTENT WITH CHEMICAL EXPOSURE TO DISINFECT THE DEVICE FOR RE-USE. BASED ON THE REPORTED COMPLAINT, THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED, HOWEVER THE DAMAGE TO THE MATERIAL ON THE DISTAL END OF THE NEURON MAX LIKELY CONTRIBUTED TO THE MARKERBAND DETACHING FROM THE CATHETER. THE DETACHED MARKERBAND WAS NOT RETURNED FOR EVALUATION. A PHOTOGRAPH PROVIDED CONFIRMED THAT THE MARKERBAND WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. FURTHER EVALUATION REVEALED THAT THE ATRAUMATIC TIP WAS FRACTURED. BASED ON THE PHOTOGRAPH PROVIDED THE FRACTURE LIKELY OCCURRED POST PROCEDURE WHILE PACKAGING FOR RETURN TO PENUMBRA. 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 · 0

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE MIDDLE CEREBRAL ARTERY (MCA) SUPERIOR BRANCH USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHEATH (8F SHORT SHEATH), A NON-PENUMBRA GUIDE CATHETER, AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE NEURON MAX INTO THE INTERNAL CAROTID ARTERY (ICA) USING THE SHEATH. WHILE ATTEMPTING TO INTRODUCE THE MICROCATHETER TO THE SUPERIOR BRANCH OF THE MCA, THE PHYSICIAN NOTICED CLOT FORMATION. UPON FURTHER INSPECTION, THE PHYSICIAN FOUND THAT THE MARKERBAND OF THE NEURON MAX HAD DISCONNECTED FROM THE TIP AND WAS FOUND IN THE MCA, AND A PIECE OF THE DISTAL END OF THE NEURON MAX HAD DETACHED AND MIGRATED INTO THE MCA. THE PHYSICIAN BELIEVED THAT THE CLOT FORMATION OCCURRED DUE TO THE MARKERBAND DETACHMENT. THE PHYSICIAN DECIDED TO ADMINISTER HEPARIN TO TREAT THE CLOT FORMATION; HOWEVER, IT DID NOT RESOLVE. THE PATIENT THEN EXPERIENCED AN ACUTE STROKE ON THE OPERATING TABLE. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE STROKE WAS CAUSED BY THE DAMAGE TO THE NEURON MAX. THE NEURON MAX, GUIDE CATHETER, AND MICROCATHETER WERE THEN REMOVED FROM THE PATIENT. THE PHYSICIAN USED ANOTHER NEURON MAX, NON-PENUMBRA MICROCATHETER, AND A STENT RETRIEVER TO SUCCESSFULLY REMOVE THE DETACHED NEURON MAX MARKERBAND AND THE DISTAL PIECE OF THE NEURON MAX AFTER TWO TO THREE PASSES. THE PROCEDURE WAS ABANDONED AT THIS POINT. THE PATIENT IS CURRENTLY STABLE AND RECOVERING IN THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS STILL IN THE ICU WITH LEFT SIDE HEMIPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310462 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. H00005204 00815948022409

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention