BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE

    MDR report key: 23330475 · Received October 17, 2025

    Report

    Report Number
    3007628272-2025-00050
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 28, 2025
    Report Date
    October 17, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085393
    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 (31546549) 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 THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A CEREBRAL INFARCTION, DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). THE PHYSICIAN ATTEMPTED TO CONNECT THE ATTACHED T-CONNECT TO THE HUB OF THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31546549), BUT THE T-CONNECTOR WAS LOOSE. IT WAS REPORTED THAT ¿EVEN WHEN THE PHYSICIAN TURNED THE VALVE FOR TIGHTENING, THERE WAS SOME REACTIVE FORCE AND THE CONNECTION REMAINED SOMEWHAT LOOSE. ALTHOUGH THE T-CONNECTOR DID NOT COME OFF DURING THE PROCEDURE, IT WAS UNSTABLE, AND THE PHYSICIAN FELT UNEASY TO USE IT.¿ CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CONCOMITANT TREVO TRAK® MICROCATHETER (STRYKER). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266827 CEREGLIDE CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31546549 10886704085393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TREVO TRAK® MICROCATHETER (STRYKER)