BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE

    MDR report key: 25086314 · Received May 5, 2026

    Report

    Report Number
    3007628272-2026-00035
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 28, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31668075) 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. 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 STROKE PROCEDURE, THE PHYSICIAN USED A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31668075) THROUGH A ZOOM¿88 ASPIRATION CATHETER (IMPERATIVE CARE). BOTH CATHETERS WERE WELL-HYDRATED (FLUSHED), THE CEREGLIDE REPORTEDLY GOT STUCK IN THE ZOOM 88. DURING THE ADVANCEMENT OF THE CEREGLIDE 71 CATHETER, THE PHYSICIAN REPORTED THAT IT FELT TIGHT AND AS A RESULT, THE PHYSICIAN REMOVED IT AND THE CEREGLIDE 71 CATHETER STRETCHED. THE PHYSICIAN TRIED THE SECOND CEREGLIDE, A 137 CM CEREGLIDE 71 CATHETER (NIC71137U / 31684676). EVERYTHING FLUSHED WELL BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2026. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE TARGET VESSEL WAS NOT EXCESSIVELY TORTUOUS. THE SECOND CEREGLIDE CATHETER WAS ALSO USED WITH THE ZOOM 88. THE INFORMATION INDICATED THAT FOR BOTH CEREGLIDE CATHETERS, THE ISSUE OCCURRED ON THE FIRST PASS. AFTER THE SECOND CEREGLIDE CATHETER, THE PHYSICIAN USED A ZOOM 7MM X 137MM TO COMPLETE THE PROCEDURE. THE ZOOM 88 WAS ALSO USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE ZOOM 88 WAS USED AGAIN WITH THE ZOOM 7MM X 137MM TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498655 CEREGLIDE CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC. 31668075 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1