BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19478435 · Received June 6, 2024

    Report

    Report Number
    3007628272-2024-00031
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 26, 2024
    Report Date
    June 25, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Adverse Event
    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, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. DIFFICULTY TRACKING A CATHETER THROUGH THE VASCULATURE IS A KNOWN PROCEDURAL OCCURRENCE. THE CONSEQUENCES OF TRACKING DIFFICULTY OCCURRING DURING CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT ANATOMY, OPERATOR TECHNIQUE, AND APPROPRIATE DEVICE SELECTION. THEREFORE, THE POTENTIAL FOR PATIENT INJURY/DEATH OCCURRING AS A RESULT OF ANY TRACKING DIFFICULTY IS REMOTE. IN ADDITION, INADEQUATE SUPPORT OF THE CATHETER¿S BODY/SHAFT SUGGESTS THERE IS EVIDENCE OF A PRODUCT MALFUNCTION, AS THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION OR OTHERWISE PERFORMED AS INTENDED, HOWEVER THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR ANOTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. IN THIS CASE, AN ARTERIAL DISSECTION WAS FOUND DURING THE PROCEDURE. THE TREATING PHYSICIAN ATTRIBUTED THIS EVENT TO THE VESSEL¿S CONDITION AND THE CEREGLIDE 71 UPWARD MOVEMENT IN REACTION TO THE WITHDRAWAL OF THE SOLITAIRE STENT-RETRIEVER. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS CLINICAL AND PROCEDURAL FACTORS INCLUDING CLOT BURDEN/CHARACTERISTICS, VESSEL CHARACTERISTICS, ANATOMICAL CHALLENGES, DEVICE INTERACTION, AND OPERATOR TECHNIQUE THAT MAY HAVE CONTRIBUTED TO THIS EVENT WITH NO INDICATION OF A DEVICE MALFUNCTION OR DEFECT. AS STATED BY THE PHYSICIAN, ¿THE SAME RESULT WOULD HAVE OCCURRED IF COMPETITOR'S DEVICES WERE USED.¿ SINCE THE CORRELATING RELATIONSHIP BETWEEN THE EVENT OF A CAROTID ARTERY DISSECTION TO THE USED CEREGLIDE71 DEVICE AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT, AND THE SEVERITY OF THE EVENT IS UNKNOWN; THE EVENT OF ¿CAROTID ARTERY DISSECTION¿ MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. 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. 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 INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUN-2024. [ADDITIONAL INFORMATION]: ON 24-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOT NUMBER OF THE CEREGLIDE CATHETER WAS 31267373. WHEN THE CEREGLIDE WAS REMOVED, THERE WAS NO APPEARANCE OF DAMAGE NOTED ON IT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE PHYSICIAN DID NOT PROVIDE ANY FURTHER INFORMATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31267373) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. UPDATED SECTIONS: B.4, D.4, G.3, G.6, H.2, H.4, 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.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), THE COMPLAINT DEVICE, A CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / LOT# UNKNOWN) WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN ATTEMPTED TO ADVANCE A GUIDEWIRE AND A TREVO TRAK¿ 21 MICROCATHETER (STRYKER) TO CROSS THE THROMBUS, BUT THE MICROCATHETER COULD NOT ADVANCE FROM THE C4 SEGMENT. ¿SOMEHOW, THE GUIDEWIRE WAS ABLE TO BE ADVANCED TO M3-4, AND SO THE MICROCATHETER TO [DISTAL M1] (M1D). THE CEREGLIDE 71 CATHETER WAS DELIVERED. HOWEVER, IT DID NOT ADVANCE SO WELL, SO THE SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC) WAS INSERTED AND DEPLOYED AT THE TARGET SITE TO RETRIEVE THE THROMBUS. WHEN THE SOLITAIRE WAS PULLED, THE CEREGLIDE 71 MOVED DISTALLY IN REACTION TO THE MOVEMENT OF THE SOLITAIRE. VASCULAR DISSECTION OF INTERNAL CAROTID ARTERY OCCURRED.¿ THE SOLITAIRE STENT RETRIEVER WAS WITHDRAWN, AND ASPIRATION FROM THE OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL) WAS APPLIED. A LARGE THROMBUS WAS RETRIEVED, BUT THE C4 AREA WAS NOT COMPLETELY RECANALIZED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED THREE TIMES USING THE UNRYU XP® ANGIOPLASTY BALLOON (KANEKA) AND A 4MM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED AT THE C4 AREA. THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. REGARDING THE DISSECTION, THE PHYSICIAN COMMENTED THAT, ¿THE C4 AREA WAS ORIGINALLY STENOSED AND THE DISSECTION MAY HAVE BEEN OCCURRED DUE TO THE VESSEL CONDITION AND THE CEREGLIDE 71 UPWARD MOVEMENT. HOWEVER, THE SAME RESULT WOULD HAVE OCCURRED IF COMPETITOR'S DEVICES WERE USED.¿ THE PATIENT WAS ABLE TO SPEAK POST-PROCEDURE. ON 05-JUN-2024, LIMITED INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE C4 SEGMENT OF THE INTERNAL CAROTID ARTERY WAS STENOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6081 132CM CEREGLIDE 71 CATHETER CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31267373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening ATLAS® STENT SYSTEM (STRYKER)| OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL)| SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC)| TREVO TRAK¿ 21 MICROCATHETER (STRYKER)| UNRYU XP® ANGIOPLASTY BALLOON (KANEKA)