BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 17263473 · Received July 5, 2023

    Report

    Report Number
    3005168196-2023-00320
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00815948022409
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE UPDATED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2023-00320: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 2. SECTION H. BOX 6. DEVICE CODE 1 AND 2. EVALUATION OF THE RETURNED NEURON MAX CONFIRMED A KINK AND PUNCTURE AT THE KINKED LOCATION. IF THE NEURON MAX IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS A KINK MAY OCCUR. SUBSEQUENT ATTEMPT TO ADVANCE AN ASPIRATION CATHETER WITH GUIDEWIRE THROUGH A KINKED CATHETER LIKELY CONTRIBUTED TO THE CATHETER LUMEN PUNCTURE, AND THE GUIDEWIRE EXITING THROUGH THE DAMAGED LOCATION. THE REPORTED PATIENT¿S TORTUOUS ANATOMY MAY HAVE CONTRIBUTED TO THE RESISTANCE DURING ADVANCEMENT. DURING EVALUATION A DEMONSTRATION ASPIRATION CATHETER COULD NOT ADVANCE PAST THE KINKED LOCATION ON THE NEURON MAX. 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. NOTE: BASED ON THE INVESTIGATION FINDINGS, THIS IS NOT CONSIDERED A REPORTABLE EVENT. THIS EVENT DID NOT AND, IF IT WERE TO RECUR, IT WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS DETERIORATION OR DEATH. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN FRACTURED THE NEURON MAX IN THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHEATH, AN ASPIRATION CATHETER AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE AN ASPIRATION CATHETER OVER THE NEURON MAX, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN DECIDED TO REMOVE THE NEURON MAX AND GUIDEWIRE FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN NOTICED THE NEURON MAX WAS KINKED. IT WAS ALSO REPORTED THAT ALTHOUGH THE NEURON MAX WAS IN THE ICA, THE GUIDEWIRE PROTRUDED THROUGH THE DAMAGED NEURON MAX AND INTO THE SUBCLAVIAN ARTERY. 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
    1788243 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. H00002138 00815948022409

    Patients

    Seq Age Sex Outcome Treatment
    1 Female