BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE

    MDR report key: 23851695 · Received December 19, 2025

    Report

    Report Number
    3007628272-2025-00064
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 5, 2025
    Report Date
    February 5, 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¿S REF. (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 132CM CEREGLIDE 57 CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGE WAS OBSERVED. THE CATHETER WAS CONNECTED TO A ROTATING HEMOSTATIC VALVE (RHV). THE VALVE WAS TIGHTENED AND NO DAMAGES NOR MALFUNCTIONS WERE IDENTIFIED. THE RHV AND CATHETER WERE FLUSHED TO IDENTIFY MISALIGNMENTS IN THE INTERACTION BETWEEN COMPONENTS; HOWEVER, NO WATER LEAKAGE WAS IDENTIFIED. THE REPORTED ISSUE IN THE COMPLAINT COULD NOT BE CONFIRMED SINCE NO DAMAGES WERE FOUND ON THE DEVICE. OTHER CLINICAL OR PROCEDURAL FACTORS, WHICH COULD NOT BE REPLICATED DURING THE ANALYSIS, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE MANUFACTURING OF THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31766630) 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. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.11. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 26-JAN-2026. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.11. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, AND WEIGHT, WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. 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. THE PRODUCT ANALYSIS TEAM REVIEWED THE PRE-SHIPMENT PHOTOS OF THE COMPLAINT DEVICE THAT WERE ADDED TO THE COMPLAINT FILE ON 15-DEC-2025. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: IN THE PHOTOS, A ROTATING HEMOSTASIS VALVE (RHV) WITH EXTENSION TUBING AND A THREE-WAY STOPCOCK WAS CONNECTED TO A CEREGLIDE 57 CATHETER. MAGNIFIED OBSERVATIONS WERE PERFORMED USING A MICROSCOPE, AND NO ANOMALIES WERE FOUND IN APPEARANCE. THE HUB WAS INSPECTED, AND NO ANOMALIES WERE FOUND. DURING THE VALVE TIGHTENING PROCESS, IT WAS CONFIRMED THAT THE TIGHTENED PORTION ROTATED BACK SLIGHTLY; HOWEVER, THE VALVE AND THE HUB REMAINED INTACT AND NO DETACHMENT OCCURRED. THE REPORTED ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED; HOWEVER, THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31766630) 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. AS PART OF J&J MEDTECH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 MECHANICAL THROMBECTOMY TARGETING AN OCCLUSION IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ISCHEMIC STROKE, THE ISSUES WITH THE 144 CM CEREGLIDE 42 CATHETER (NIC42144C / 31766627) AND THE 132CM CEREGLIDE 57 CATHETER (NIC57132C / 31766630) WERE NOTICED DURING THE PROCEDURE PREPARATION. THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). IT WAS REPORTED THAT ¿WHEN THE PRODUCT-SUPPLIED LUER VALVE WAS ATTACHED TO TWO CEREGLIDE CATHETERS DURING THE USUAL PREPARATION, BOTH EXHIBITED A SENSATION OF NOT BEING ABLE TO BE FULLY SCREWED ON; EVEN WHEN IT SEEMED THEY HAD BEEN TIGHTENED COMPLETELY, THEY APPEARED TO LOOSEN SLIGHTLY ONCE RELEASED.¿ THE PROCEDURE WAS CONTINUED WITH SOME CONCERN; IT WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT. THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF THE ISSUE AND REQUESTED AN INVESTIGATION. THE DEVICES WERE INSPECTED BY THE CERENOVUS SALES REPRESENTATIVE, THE SAME ISSUE WAS EXPERIENCED ¿ THE INABILITY TO FULLY SCREW THE VALVE ON, WHICH IS AN OCCURRENCE THAT HAS NOT BEEN PREVIOUSLY ENCOUNTERED. ON 10-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, BOTH CATHETERS WERE USED FOR THE THROMBECTOMY PROCEDURE EVEN THOUGH THERE WAS THE REPORTED ISSUE WITH THE LUER VALVE. THE INFORMATION INDICATED THAT BOTH CEREGLIDE 42 AND CEREGLIDE 57 WERE USED BUT IT WAS NOT SPECIFIED WHICH OF THE TWO WAS USED TO COMPLETE THE PROCEDURE. ON 14-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS A JAPANESE FEMALE IN HER 70S. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ON 15-DEC-2025, PRE-SHIPMENT PHOTOS OF THE COMPLAINT DEVICE WERE ADDED TO THE COMPLAINT FILE. THE PHOTOS WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242495 CEREGLIDE CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC. 31766630 10886704086529

    Patients

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