BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 22436397 · Received July 8, 2025

    Report

    Report Number
    3007628272-2025-00032
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 19, 2025
    Report Date
    August 18, 2025
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    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. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE REPORTED FAILURE COULD NOT BE EVALUATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31491254 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING RECORD EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE POSSIBLE VESSEL CHARACTERISTICS, SPECIFICALLY THE SEVERE TORTUOSITY AT VESSEL BRANCH THAT MAY HAVE CONTRIBUTED TO THE EVENT. 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. 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. . THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, G3, G6, H2, H6 AND H11. CORRECTION: H6. MEDICAL DEVICE PROBLEM CODE: DEFORMATION DUE TO COMPRESSIVE STRESS (A040601) 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 THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY, M1SEGMENT TO TREAT ACUTE ISCHEMIC STROKE. THE 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31491254) WAS ATTEMPTED TO BE USED TO RETRIEVE A THROMBUS AT THE MIDDLE CEREBRAL ARTERY M1. DURING DELIVERY OF THE CEREGLIDE 71, IT GOT KINKED AT THE ROOT SECTION AND BECAME UNUSABLE. THE CEREGLIDE 71 WAS REPLACED WITH ANOTHER NEW ASPIRATION CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT THERE WAS NO ADDITIONAL INTERVENTION NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-JUL-2025 INDICATED THAT THE DEVICE HAD BEEN ADVANCED OR WITHDRAWN AGAINST RESISTANCE, NO FURTHER DETAILS ARE AVAILABLE. THERE WERE NO PROCEDURAL PROLONGATION/DELAY DUE TO THE EVENT. AORTA WAS TYPE 3 (RELATIVE SEVERE TORTUOSITY AT BRANCH). NO CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071509 132CM CEREGLIDE 71 CATHETER CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC. 31491254 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CHIKAI® NEUROVASCULAR GUIDEWIRE (ASAHI INTECC)| PHENOM¿ MICROCATHETER (UNSPECIFIED BRAND)| UNKNOWN EMBOGUARD BALLOON