BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEREGLIDE 57

    MDR report key: 25095921 · Received May 6, 2026

    Report

    Report Number
    3007628272-2026-00037
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 12, 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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31862187 NUMBER, AND NO INTERNAL ACTIONS WERE 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. CATHETER KINKING DURING CLINICAL USE IS A KNOWN AND COMMON OCCURRENCE AND IS TYPICALLY RELATED TO ANATOMY, TECHNIQUE, PHYSICIAN SKILL, AND VESSEL TORTUOUSITY. IF THE OPERATOR ENCOUNTERS KINKING OR DAMAGE DURING CLINICAL USE, THEY ARE CLINICALLY TRAINED TO IMMEDIATELY DISCONTINUE MANIPULATIONS AND REMOVE THE PRODUCT. THIS MAY REQUIRE INSERTION OF AN ADDITIONAL DEVICE, WHICH CAN CAUSE INTRA-PROCEDURE PROLONGATION. 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. 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 THAT DURING A MECHANICAL THROMBECTOMY TO TREAT CEREBRAL INFARCTION, THE 132CM CEREGLIDE 57 CATHETER (PRODUCT CODE: NIC57132C, LOT NUMBER: 31862187) COULD NOT BE USED DUE TO KINKING. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN OF A CONTINUOUS FLUSH WAS DONE. THE TARGET LESION IS NOT KNOWN. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAY-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453461 CEREGLIDE 57 CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31862187 10886704086529

    Patients

    Seq Age Sex Outcome Treatment
    1