BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 7401166 · Received April 5, 2018

    Report

    Report Number
    3005168196-2018-00716
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 9, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012179
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS: THE DISTAL TIP OF THE NEURON MAX EXTRUSION WAS PUNCTURED AND SHOWED SOME OVALIZATION. THE DISTAL END OF THE BRAIDED SHAFT WAS DEFORMED. THE DISTAL EXTRUSION WAS REMOVED BY THE PENUMBRA INVESTIGATOR AND THE MARKER BAND WAS NOT PRESENT. CONCLUSIONS: EVALUATION OF THE NEURON MAX CONFIRMED THAT THE MARKER BAND WAS MISSING. IN ADDITION, THE DISTAL END OF THE BRAIDED SHAFT SHOWED SIGNS OF OVALIZATION. DURING INSERTION INTO THE PATIENT, IT IS LIKELY THAT THE NEURON MAX TIP BECAME WEAKENED AND OVALIZED. IN ADDITION, THE NEURON MAX HAS HYDROPHILIC COATING AT THE DISTAL TIP, IT IS LIKELY THAT THE NEURON MAX WAS GRIPPED FIRMLY TO OVERCOME THE DEVICE LUBRICITY DURING THE INSERTION INTO THE PATIENT ANATOMY IN SUCH A WAY THAT COULD HAVE CAUSED OVALIZATION ON THE DISTAL END OF THE BRAIDED SHAFT AT THE LOCATION OF THE MARKER BAND. THE OVALIZATION OBSERVED ON THE DISTAL TIP MAY HAVE CONTRIBUTED TO THE SEPARATION OF THE MARKER BAND FROM THE NEURON MAX. FURTHER EVALUATION OF THE NEURON MAX REVEALED THAT THE EXTRUSION AT THE DISTAL TIP WAS PUNCTURED. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. THE NEURON MAX MARKER BAND AND THE NON-PENUMBRA CATHETER IDENTIFIED IN THE COMPLAINT WERE NOT RETURNED TO PENUMBRA FOR EVALUATION. PENUMBRA CATHETERS ARE VISUALLY 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 MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT A FLOW DIVERTER USING A NEURON MAX AND A NON-PENUMBRA DISTAL ACCESS CATHETER, THE NEURON MAX RADIOPAQUE MARKER MIGRATED FROM THE TIP OF THE NEURON MAX AND INTO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE RADIOPAQUE MARKER USING A SNARE DEVICE,BUT IT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN USED A STENT RETRIEVER DEVICE THROUGH A NON-PENUMBRA CATHETER TO SUCCESSFULLY REMOVE THE RADIOPAQUE MARKER FROM THE RIGHT ANTERIOR TEMPORAL ARTERY WITH NO CIRCULATION DAMAGE. THE PROCEDURE WAS ENDED AFTER REMOVAL OF THE RADIOPAQUE MARKER AND THE FLOW DIVERTER WAS NOT PLACED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242384 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F79497 00814548012179

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention