BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19704187 · Received July 9, 2024

    Report

    Report Number
    3007628272-2024-00040
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 9, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31327435 NUMBER, AND NO NON-CONFORMANCE'S 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 CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A THROMBECTOMY OF A STROKE AT THE MIDDLE CEREBRAL ARTERY, SEGMENT M1, A 132CM CEREGLIDE 71 ASPIRATION CATHETER (NIC71132C, 31327435) WAS USED AND COULD NOT BE REMOVED. WAS PULLED AND COULD NO LONGER BE USED. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JUL-2024 INDICATED THAT THERE WAS NO RESISTANCE ENCOUNTERED. THE CATHETER DID NOT APPEAR TO BE DAMAGED; THE DEVICE WAS COMPLETELY FINE. THE CATHETER WAS SLOWLY WITHDRAWN COMPLETELY, NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PROCEDURE WAS ABLE TO BE CONTINUED AND THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458817 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY CERENOVUS, INC. 31327435

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female