BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19845651 · Received July 26, 2024

    Report

    Report Number
    3007628272-2024-00043
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 7, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    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¿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. SECTION E.1: THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31294255) 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. THE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINER OF THE CEREGLIDE71 INTERMEDIATE CATHETER WAS FOUND TO BE DELAMINATED, WHICH RESULTED IN FAILURE TO FULLY ADVANCE OTHER DEVICES THROUGH THE CEREGLIDE71 DEVICE; PER THE EVENT DESCRIPTION, ¿CHIKAI GUIDEWIRE AND PHENOM 21 MICROCATHETER WERE UNABLE TO ADVANCE AFTER THE 3CM OF THEIR TIP WAS ADVANCED, SO USE OF THEM WAS GIVEN UP.¿ OBSTRUCTION OF A DEVICE IS A KNOWN EVENT. REMOVAL AND EXCHANGE OF DEVICES IS COMMON ROUTINE PRACTICE IN ENDOVASCULAR PROCEDURES. IN THIS CASE, THE EXCHANGE OF THE DEVICES RESULTED IN LOSS OF INTRACRANIAL TARGET POSITION, WHICH REQUIRES RE-ACCESSING THE TARGET SITE WITH INCREASED POTENTIAL FOR VESSEL TRAUMA, VESSEL SPASM, OR ISCHEMIA/INFARCT. IN ADDITION, DELAMINATION OF THE CEREGLIDE71 PTFE INNER LINER CAN RESULT IN THE SEPARATION AND EMBOLIZATION OF THE COATING PIECES OR PARTICLES, WITH THE POTENTIAL FOR ISCHEMIA OR INFARCT. SINCE THE EVENTS RESULTED IN LOSS OF INTRACRANIAL TARGET POSITION AND THE NEED TO REPLACE THE DEVICES DURING AN EMERGENCY THROMBECTOMY PROCEDURE, THIS EVENT 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. . 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 30-JUL-2024. [ADDITIONAL INFORMATION]: ON 30-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE EMBOTRAP III REVASCULARIZATION DEVICE MADE A TOTAL OF 3 PASSES. THERE WAS NO DEVICE PERFORMANCE ISSUE / DEVICE MALFUNCTION ASSOCIATED WITH THE EMBOTRAP III DEVICE. THE INFORMATION ALSO INDICATED THAT THERE WAS ¿NO EVIDENCE FOUND FOR ANY DAMAGES ON THE CEREGLIDE LINER CAUSED BY THE EMBOTRAP III, ONLY [THE] PHYSICIAN¿S IMAGINATION.¿ THERE WAS NO WITHDRAWAL DIFFICULTY EXPERIENCED WITH THE EMBOTRAP III DEVICE. THE EMBOTRAP III DID NOT APPEAR DAMAGED IN ANY WAY AT THE END OF THE PROCEDURE. THE INFORMATION CONFIRMED THAT THE THROMBUS WAS RETRIEVED ON THE 5TH PASS VIA ADAPT USING THE EMBOTRAP III DEVICE AND THE ESPERANCE CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. FURTHER INFORMATION IS NOT AVAILABLE. UPDATED SECTIONS: B.4, G.3, G.6, H.2, 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 THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE TARGETING AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) VIA GROIN ACCESS, AN 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 0000267140) AND A CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / 31294255) WERE USED. IT WAS REPORTED THAT THE EMBOGUARD BGC WAS DAMAGED DURING INSERTION INTO AN 8F LONG SHEATH (UNSPECIFIED BRAND) BECAUSE THE SHEATH HAD BEEN BENT AND THE EMBOGUARD BGC GOT KINKED AFTER TWO (2) PASSES. AS A RESULT, A BRANCHOR BGC (ASAHI-INTECC) WAS USED WITH A STIFF WIRE AND A THIRD PASS WAS MADE VIA THE COMBINED TECHNIQUE WITH AN EMBOTRAP III (CATALOG AND LOT # UNKNOWN) AND THE CEREGLIDE 71 INTERMEDIATE CATHETER. IN A FOURTH PASS, A CHIKAI¿ NEURO GUIDEWIRE (ASAHI INTECC) AND A PHENOM¿ 21 MICROCATHETER (MEDTRONIC) WERE INSERTED INTO THE CEREGLIDE 71 INTERMEDIATE CATHETER, BUT THE CHIKAI GUIDEWIRE AND THE PHENOM MICROCATHETER WERE UNABLE TO ADVANCE AFTER 3 CM OF THEIR TIPS WERE ADVANCED, THEREFORE, THE PHYSICIAN GAVE UP USING THEM AND REPLACED THEM WITH AN ESPERANCE¿ 5F CATHETER (WALLABY MEDICAL), IT WAS USED VIA THE COMBINED TECHNIQUE WITH THE EMBOTRAP III DEVICE, BUT THE THROMBUS COULD NOT BE RETRIEVED. THE ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) WAS USED IN A FIFTH PASS, AND THE THROMBUS WAS SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. IT WAS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE CEREGLIDE 71 INTERMEDIATE CATHETER WAS CUT AND IT WAS FOUND THAT THE CHIKAI GUIDEWIRE AND THE PHENOM¿ 21 MICROCATHETER DID NOT PASS THROUGH BECAUSE THE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINER HAD PEELED OFF. THE PHYSICIAN COMMENTED THAT ¿THE DAMAGE MIGHT HAVE BEEN CAUSED BY THE EMBOTRAP III AND HARD THROMBI BEING TAKEN IN.¿ ON 15-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PTFE LINER HAD PEELED OFF INSIDE THE CEREGLIDE 71 INTERMEDIATE CATHETER, BUT THE EXACT LOCATION CANNOT BE CONFIRMED. THE CHIKAI AND THE PHENOM 21 MICROCATHETER COULD NOT BE ADVANCED 3 CM FROM THE TIP. THE CEREGLIDE 71 INTERMEDIATE CATHETER MADE A TOTAL OF TWO (2) PASSES, THE SECOND AND THE THIRD PASS. IT IS POSSIBLE THAT THERE WAS A KINK / BEND AT THE PROXIMAL SECTION OF THE CEREGLIDE 71 INTERMEDIATE CATHETER, BUT IT CANNOT BE CONFIRMED. THE INFORMATION CONFIRMED THAT THE KINK ON THE EMBOGUARD BGC WAS FOUND AFTER 2 PASSES. ON 17-JUL-2024, LIMITED ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, PHOTOS OF THE CEREGLIDE ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459956 132CM CEREGLIDE 71 CATHETER CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31294255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 8F LONG SHEATH (UNSPECIFIED BRAND)| CHIKAI¿ NEURO GUIDEWIRE (ASAHI INTECC)| PHENOM¿ 21 MICROCATHETER (MEDTRONIC)| UNKNOWN EMBOTRAP III