BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE

    MDR report key: 23489717 · Received November 6, 2025

    Report

    Report Number
    3007628272-2025-00056
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 23, 2025
    Report Date
    February 26, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    QJP
    UDI-DI
    10886704086024
    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 REF# (B)(4) INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3 AND H11. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

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¿OK¿. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE CEREGLIDE92 122CM US WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND ONE KINKED CONDITION WAS FOUND AT THE DISTAL SEGMENT OF THE CATHETER AT 32 CM. ALSO, A COMPRESSED SECTION OF 13CM WAS FOUND AT THIS POINT. THE ISSUE REGARDING CATHETER STIFFNESS AND SUBSEQUENTLY BEING FOUND STRETCHED CAN BE CONFIRMED BASED ON THE CONDITIONS OBSERVED DURING VISUAL ANALYSIS. THE MULTIPLE DAMAGES FOUND IN THE DEVICE MAY BE THE RESULT OF THE DIFFICULTIES EXPERIENCED WHILE MANEUVERING THE DEVICE. AS NO MANUFACTURING DEFECTS WERE IDENTIFIED, THE FAILURE MODE EXPERIENCED MAY HAVE BEEN THE RESULT OF OTHER FACTORS, EITHER ISOLATED OR IN COMBINATION, SUCH AS INTERACTION WITH OTHER ACCESSORY DEVICES, ANATOMICAL CONDITIONS OR OTHER CLINICAL FACTORS EXPERIENCED DURING THE PROCEDURE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTIONS RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGE FROM LEAVING THE FACILITY. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO INTERNAL ACTION IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: DO NOT USE A DEVICE THAT HAS BEEN DAMAGED IN ANY WAY; REPLACE WITH A NEW CEREGLIDE 92 CATHETER SYSTEM. A DAMAGED DEVICE MAY CAUSE COMPLICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, THE PHYSICIAN WAS USING THE CEREGLIDE 92 CATHETER SYSTEM (SBC92122CA, LOT UNKNOWN) AND ON REMOVAL STIFFNESS WAS FELT. THE USER HAD TO SLIGHTLY ADJUST AND THEN REMOVE SLOWLY. THE USER THEN NOTICED THAT THE CATHETER HAD STRETCHED. HE BELIEVES IT WILL BE DOWN TO THE TORTUOSITY AND MULTIPLE PASSES WITH THE ASPIRATION CATHETER. THE PRODUCT ISSUE DID NOT IMPACT THE CASE OR CAUSE ANY HARM TO THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-NOV-2025 INDICATED THAT THERE MAY HAVE BEEN AN INTERACTION WITH THE TERUMO DESTINATION LONG SHEATH WHICH CAUSED THE PRODUCT ISSUE DUE TO THE DESTINATION STIFFNESS. THE CATHETER WAS REMOVED FROM THE PATIENT ¿OK¿. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299261 CEREGLIDE CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP CERENOVUS, INC. 31747750 10886704086024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO DESTINATION LONG SHEATH