BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE

    MDR report key: 23854536 · Received December 19, 2025

    Report

    Report Number
    3007628272-2025-00066
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 19, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. 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 (31673300) 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 OF AN OSTIUM INTERNAL CAROTID ARTERY OCCLUSION, AFTER THE EMBOGUARD BALLOON GUIDE CATHETER (BGC) (CATALOG / LOT# UNKNOWN) WAS PLACED IN THE DISTAL COMMON CAROTID ARTERY, AN ATTEMPT WAS MADE TO ADVANCE THE 125CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71125C / 31673300), BUT RESISTANCE WAS FELT INSIDE THE EMBOGUARD. THE 125CM CEREGLIDE 71 INTERMEDIATE CATHETER WAS REMOVED FROM THE PATIENT¿S ANATOMY AND IT WAS NOTED THAT THE TIP OF THE CEREGLIDE CATHETER WAS FLATTENED. THE 125CM CEREGLIDE 71 INTERMEDIATE CATHETER WAS REPLACED WITH ANOTHER OF THE SAME PRODUCT CODE (NIC71125C). IT WAS REPORTED THAT THE REPLACEMENT CEREGLIDE CATHETER WAS ADVANCED WITHOUT ANY ISSUE. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 08-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, RESISTANCE OCCURRED DURING THE DELIVERY OF THE CEREGLIDE 71 CATHETER INSIDE THE EMBOGUARD. ¿THE CEREGLIDE71 WAS REMOVED FROM PATIENT BODY AND CONFIRMED TO BE FLATTENED AT THE DISTAL TIP. THE CEREGLIDE71 DID NOT CONTACT BLOOD VESSEL.¿ ON 11-DEC-2025, ADDITIONAL CLARIFYING INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO ISSUE WITH THE EMBOGUARD BGC, IT WAS NOT REPLACED. THE CEREGLIDE 71 WAS REPLACED WITH ANOTHER CEREGLIDE 71. ON 19-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED, PER THE INFORMATION, THE VESSEL TORTUOSITY ¿WAS NOT SO SEVERE.¿ RESISTANCE WAS FIRST FELT DURING THE ADVANCEMENT OF THE DEVICE INSIDE THE EMBOGUARD, AROUND THE BRACHIOCEPHALIC ARTERY. THE CATHETER WAS REPORTED TO BE ¿FLATTENED APPROXIMATELY 10 CM FROM THE TIP.¿ THE INFORMATION ALSO INDICATED THAT THERE WAS NO LOSS OF CEREBRAL TARGET AS A RESULT OF THE ISSUE REPORTED; IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE TREVO TRAK® MICROCATHETER (STRYKER). THE EMBOGUARD USED WAS A 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 9948491); THERE WAS NO ISSUE WITH THE EMBOGUARD, AND IT IS NOT AVAILABLE FOR RETURN. THE INFORMATION INDICATED THAT THERE WAS A DELAY OF ABOUT 2 MINUTES. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 08-DEC-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626398 CEREGLIDE CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31673300 10886704085379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EMBOGUARD 87, 95 CM.| TREVO TRAK® MICROCATHETER (STRYKER).