BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOGUARD

    MDR report key: 24378277 · Received February 18, 2026

    Report

    Report Number
    3011370111-2026-00015
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 18, 2026
    Manufacturer
    NEURAVI LTD.
    Product Code
    QJP
    UDI-DI
    10886704082750
    PMA / PMN Number
    K212340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (9914820) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE ON A PATIENT WITH TORTUOUS VASCULATURE THAT HAD CALCIFIED SPOTS IN THE INTERNAL CAROTID ARTERY (ICA), THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795C / 9914820) THAT WAS USED BECAME KINKED. THE PHYSICIAN REPLACED IT WITH A NEURON MAX DEVICE AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. NO NEGATIVE IMPACT ON THE PATIENT. ON 11-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ACCESS POINT OF THE PROCEDURE WAS FEMORAL. AN 8FR TERUMO RADIFOCUS INTRODUCER SHEATH WAS USED. A PEEL-AWAY SHEATH WAS ALSO USED. THE EMBOGUARD HAD NOT BEEN INFLATED. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. PER THE INFORMATION, THE LOT NUMBER OF THE EMBOGUARD DEVICE WAS 9914820. THE PHYSICIAN DID NOT CONSIDER THE REPORTED 5-MINUTE DELAY IN THE PROCEDURE TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270799 EMBOGUARD CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP NEURAVI LTD. 9914820 10886704082750

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female 8FR RADIFOCUS® INTRODUCER SHEATH (TERUMO)