BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE 57

    MDR report key: 25150057 · Received May 12, 2026

    Report

    Report Number
    3007628272-2026-00038
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 27, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704086529
    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 REF#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D2B: PROCODE IS NRY/QJP. SECTION H3: 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. 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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M2 SEGMENT OCCLUSION USING A COMBINED TECHNIQUE. WHEN ATTEMPTING TO PERFORM ANGIOGRAPHY USING CONTRAST THROUGH THE 132CM CEREGLIDE 57 CATHETER (PRODUCT CODE: NIC57132C, LOT NUMBER: 31817275), IMAGING COULD NOT BE OBTAINED. ON INSPECTION, THE PHYSICIAN OBSERVED CONTRAST LEAKING FROM THE GAP BETWEEN THE T-CONNECTOR AND THE HUB. THE PHYSICIAN ATTEMPTED TO FIRMLY TIGHTEN THE BASE OF THE CONNECTOR BY ROTATING IT, BUT IT ROTATED BACK. SO, THE CEREGLIDE 57 WAS REPLACED WITH A DIFFERENT PRODUCT, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE CEREGLIDE 57 ITSELF APPEARED TO HAVE NO PROBLEM AND SUSPECTED THE ISSUE WAS WITH THE T-CONNECTOR. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS PHENOM MICROCATHETER. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PROBLEMS PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526698 CEREGLIDE 57 CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31817275 10886704086529

    Patients

    Seq Age Sex Outcome Treatment
    1