BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19935237 · Received August 7, 2024

    Report

    Report Number
    3007628272-2024-00044
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.3: DATE OF EVENT: THE DATE OF THE EVENT IS NOT KNOWN. SECTION D.2B: PROCODE IS NRY/QJP. SECTION E.1: THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: VISUAL: THE CATHETER WAS RECEIVED WITH DISTAL MARKER BAN CRUSHED, AND MATERIAL NECKING APPROXIMATELY 2 MM FROM THE TIP FOR APPROXIMATELY 2 MM. THE INNER PTFE LINER IS DELAMINATED FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A SECTION. THE DELAMINATION EXTENDS TO APPROXIMATELY 4.8 CM FROM THE TIP. THE MOST PROXIMAL 6 MM OF THE DELAMINATED PTFE LINER IS DOUBLED OVER ON ITSELF. THERE WAS A SMALL SPLIT / PERFORATION IN THE OUTER POLYMER JACKET SEGMENT, ALIGNED WITH THE ANGLE OF THE BRAID WIRE AT APPROXIMATELY THE PROXIMAL END OF THE DELAMINATED SEGMENT. THERE WERE SEVERAL FLATTENED OR PARTIALLY FLATTENED SPOTS ON THE CATHETER. THEY WERE FOUND AT 5.7 CM PROXIMAL TO THE DISTAL TIP, 8.5 CM PROXIMAL TO THE DISTAL TIP, 20.9 CM PROXIMAL TO THE DISTAL TIP, AND 9.4 CM DISTAL TO THE PROXIMAL ID BAND. AN ATTEMPT WAS MADE TO RECREATE THE DELAMINATION PHENOMENON BY STRETCHING PRODUCT RETAINS FROM LOT 31028722, WHICH WAS A LOT FROM THE ORIGINAL CEREGLIDE PQ/PVE FOR MANUAL MAGIC TOUCH. THE CATHETERS WERE STRETCHED SO THAT THE ORIGINAL APPROXIMATE 5CM LONG SECTIONS WERE STRETCHED TO APPROXIMATELY 13 CM. AFTERWARD DEVICES WERE PASSED THROUGH THE LUMEN. NO DELAMINATION WAS ABLE TO BE CREATED ON THESE NOMINALLY FUSED PRODUCTS. CONCLUSION: THE CATHETER TIP EXPERIENCED TENSION / ELONGATION OF THE DISTAL REGION OF THE CATHETER WHICH CAUSED THE INNER PTFE LINER TO DELAMINATE FROM THE OUTER POLYMER JACKET THROUGHOUT THE MATERIAL. THERE WAS A SMALL SLIT IN THE POLYMER JACKET CORRESPONDING TO THE END OF THE DELAMINATED SEGMENT. BECAUSE OF THE FLATTENED SECTIONS ALSO FOUND ON THE CATHETER IN MULTIPLE SPOTS, AND THE CRUSHED MARKER BAND AT THE TIP, IT IS SUSPECTED THAT THE RHV USED ON THE CATHETER OD WAS TIGHTENED EXCESSIVELY CAUSING STRETCHING OF THE CATHETER WHILE WITHDRAWING FROM THE PATIENT. BASED ON ELONGATION TRIALS ON PRODUCT RETAINS FROM LOT 31028722, A NOMINALLY ASSEMBLED / FUSED PRODUCT DOES NOT DELAMINATE WHEN ELONGATED. THE COMPLAINT PRODUCT IS SUSPECTED TO HAVE A SUB-OPTIMAL FUSE BETWEEN THE PTFE LINER AND THE OUTER POLYMER JACKET. BASED ON THIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31327435 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING RECOMMENDATION: - EXERCISE CARE IN HANDLING THE INTERMEDIATE CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. 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 REPORT AN UPDATED / REVISED PRODUCT INVESTIGATION. INVESTIGATION SUMMARY: VISUAL: THE CATHETER WAS RECEIVED WITH DISTAL MARKER BAN CRUSHED, AND MATERIAL NECKING APPROXIMATELY 2 MM FROM THE TIP FOR APPROXIMATELY 2 MM. THE INNER PTFE LINER IS DELAMINATED FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A SECTION. THE DELAMINATION EXTENDS TO APPROXIMATELY 4.8 CM FROM THE TIP. THE MOST PROXIMAL 6 MM OF THE DELAMINATED PTFE LINER IS DOUBLED OVER ON ITSELF. THERE WAS A SMALL SPLIT / PERFORATION IN THE OUTER POLYMER JACKET SEGMENT, ALIGNED WITH THE ANGLE OF THE BRAID WIRE AT APPROXIMATELY THE PROXIMAL END OF THE DELAMINATED SEGMENT. THERE WERE SEVERAL FLATTENED OR PARTIALLY FLATTENED SPOTS ON THE CATHETER. THEY WERE FOUND AT 5.7 CM PROXIMAL TO THE DISTAL TIP, 8.5 CM PROXIMAL TO THE DISTAL TIP, 20.9 CM PROXIMAL TO THE DISTAL TIP, AND 9.4 CM DISTAL TO THE PROXIMAL ID BAND. AN ATTEMPT WAS MADE TO RECREATE THE DELAMINATION PHENOMENON BY STRETCHING PRODUCT RETAINS FROM LOT 31028722, WHICH WAS A LOT FROM THE ORIGINAL CEREGLIDE PQ/PVE FOR MANUAL MAGIC TOUCH. THE CATHETERS WERE STRETCHED SO THAT THE ORIGINAL ~5CM LONG SECTIONS WERE STRETCHED TO ~13 CM. AFTERWARD DEVICES WERE PASSED THROUGH THE LUMEN. NO DELAMINATION WAS ABLE TO BE CREATED ON THESE NOMINALLY FUSED PRODUCTS. CONCLUSION: THE CATHETER TIP EXPERIENCED TENSION / ELONGATION OF THE DISTAL REGION OF THE CATHETER WHICH CAUSED THE INNER PTFE LINER TO DELAMINATE FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A MATERIAL. THERE WAS A SMALL SLIT IN THE 42A POLYMER JACKET CORRESPONDING TO THE END OF THE DELAMINATED SEGMENT. BECAUSE OF THE FLATTENED SECTIONS ALSO FOUND ON THE CATHETER IN MULTIPLE SPOTS, AND THE CRUSHED MARKER BAND AT THE TIP, IT IS SUSPECTED THAT THE RHV USED ON THE CATHETER OD WAS TIGHTENED EXCESSIVELY CAUSING STRETCHING OF THE CATHETER WHILE WITHDRAWING FROM THE PATIENT. THE DELAMINATION FAILURE WAS NOT ABLE TO BE REPRODUCED BY EXTREME ELONGATION ON PRODUCT RETAINS FROM PQ PVE LOT 31028722. BASED ON THIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31327435 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING RECOMMENDATION: EXERCISE CARE IN HANDLING THE INTERMEDIATE CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. 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, THE FIRST PASS WAS ASPIRATION ONLY WITH THE CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / 31327435), WITH ENVOKE¿ MICROCATHETER (NEUROVASC TECHNOLOGIES), AND TRANSEND¿ EX PLATINUM GUIDEWIRE (STRYKER); NO SNAKING AND TICI 2C/3 WAS NOT ACHIEVED. THE SECOND PASS WAS ASPIRATION ONLY WITH THE SAME DEVICES AS THE FIRST PASS (CEREGLIDE 71 INTERMEDIATE CATHETER, ENVOKE MICROCATHETER, AND TRANSEND GUIDEWIRE) WITHOUT SNAKING AND TICI SCORE 2C/3 STILL COULD NOT BE ACHIEVED. ON THE THIRD PASS, A STENT RETRIEVER, THE 5MM X 40MM ENVI¿ STENT RETRIEVER (NEUROVASC TECHNOLOGIES), WAS INTRODUCED AND USED WITH THE CEREGLIDE 71 INTERMEDIATE CATHETER AND STILL COULD NOT ACHIEVE TICI 2C/3. ON THE FOURTH ATTEMPT, THE MICROCATHETER, GUIDEWIRE, AND CEREGLIDE 71 INTERMEDIATE CATHETER WAS USED WITH THE STENT RETRIEVER, HOWEVER, THE GUIDEWIRE AND MICROCATHETER GOT STUCK AT THE DISTAL END OF THE CEREGLIDE CATHETER AND THE PHYSICIAN COULD NOT ADVANCE THEM ANY FURTHER. IT WAS REPORTED THAT THE PHYSICIAN DID NOT WANT TO FORCE IT. IT WAS ¿AT APPROXIMATELY THE SAME AREA WHERE [HIS] COLLEAGUE FOUND THE TEAR IN THE DISTAL SHAFT WITH [ANOTHER CASE].¿ IT WAS REPORTED THAT ¿IT SEEMS LIKE THE STENT RETRIEVER INTERACTION HAS RUINED THE INSIDE OF THE CEREGLIDE CATHETER AT THE DISTAL TIP SOMEHOW, THAT IS WHY HE COULD NOT RE-INTRODUCE THE MICROCATHETER AND GUIDEWIRE.¿ THE PHYSICIAN DECIDED TO REPLACE THE CEREGLIDE 71 INTERMEDIATE CATHETER WITH A SOFIA INTERMEDIATE CATHETER AND HE HAD NO ISSUES INTRODUCING THE MICROCATHETER AND GUIDEWIRE THROUGH A NEW CATHETER. THE PHYSICIAN COMMENTED THAT ¿HE THINKS IT IS PROBABLY NEAR A TRANSITION ZONE IN THE [CEREGLIDE] CATHETER,¿ BECAUSE IT WAS THE SECOND TIME IN THE SAME AREA THAT SEEMS TO BE IMPACTED BY THE STENT RETRIEVER. THE PHYSICIAN THOUGHT THAT FORCING WOULD CAUSE THE CEREGLIDE TO BREAK / KINK. THE REPORTED ISSUE PROLONGED THE PROCEDURE BY 3 MINUTES. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 07-AUG-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066408 132CM CEREGLIDE 71 CATHETER CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31327435 10886704085393

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown ENVI¿ STENT RETRIEVER (NEUROVASC TECHNOLOGIES)| ENVOKE¿ MICROCATHETER (NEUROVASC TECHNOLOGIES)| MERCI® 9F BALLOON GUIDE CATHETER (STRYKER)| TRANSEND¿ EX PLATINUM GUIDEWIRE (STRYKER)