BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IC 71, 132 CM, CE

    MDR report key: 18987812 · Received March 27, 2024

    Report

    Report Number
    3007628272-2024-00019
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 15, 2024
    Report Date
    March 27, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO:(B)(4) . INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6) . THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31214452) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. 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 PROCEDURE TARGETING A BASILAR ARTERY OCCLUSION VIA A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT), THE CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / 31214452) WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU); CONTINUOUS FLUSH WAS MAINTAINED. AFTER PREPARATION, ATTEMPTS WERE MADE TO CONNECT THE SUPPLIED T-CONNECTOR TO THE HUB ON THE CEREGLIDE 71 SIDE, BUT THE THREADED PART DID NOT ENGAGE. THE T-CONNECTOR WAS DISCARDED AND REPLACED WITH THE HOSPITAL¿S Y-CONNECTOR WHICH COULD BE CONNECTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. IT WAS ALSO REPORTED THAT THE PATIENT¿S POST-OPERATIVE CONDITION ¿WAS NOT SO GOOD.¿ ON 27-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE LOT NUMBER WAS 31214452. PER THE INFORMATION, THE STATUS OF THE PATIENT BEFORE THE START OF THE PROCEDURE WAS ¿LOST [OF] CONSCIOUSNESS¿ AND THE PATIENT¿S POST-OP CONDITION OF ¿NOT SO GOOD¿ WAS CONFIRMED TO HAVE ¿NO ASSOCIATION WITH THE CEREGLIDE USE.¿ THE PHYSICIAN COMMENTED THAT ¿ALTHOUGH RECANALIZATION WAS ACHIEVED, THE PATIENT'S POSTOPERATIVE CONDITION WAS NOT SO GOOD BECAUSE A CONSIDERABLE TIME HAD PASSED SINCE THE ONSET OF THE BA OCCLUSION.¿ THE INFORMATION INDICATED THAT THE MOST CURRENT STATUS OF THE PATIENT IS ¿ NOT SO GOOD.¿ THE INFORMATION ALSO INDICATED THAT WHEN THE CEREGLIDE WAS REMOVED, THERE WAS NO APPEARANCE OF DAMAGE NOTED ON IT. THE PROCEDURE WAS COMPLETED USING THE CEREGLIDE AND THE Y-CONNECTOR FROM THE HOSPITAL. THE PROCEDURE WAS ¿SLIGHTLY DELAYED, BUT IT WAS NOT CLINICALLY SIGNIFICANT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130021 IC 71, 132 CM, CE CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31214452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 6FR FUBUKI GUIDE SHEATH (ASAHI INTECC)| T-CONNECTOR (UNSPECIFIED BRAND)| Y-CONNECTOR (UNSPECIFIED BRAND)