BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19845546 · Received July 26, 2024

    Report

    Report Number
    3007628272-2024-00042
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 15, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    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, SEX, 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 / REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE PRODUCT ANALYSIS TEAM CONDUCTED A REVIEW OF THE PRE-SHIPMENT PHOTOS THAT WERE ADDED TO THE COMPLAINT ON 22-JUL-2024. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: A SERIES OF PHOTOS OF THE COMPLAINT CEREGLIDE HAVE BEEN MADE AVAILABLE PRIOR TO RETURN FOR ANALYSIS. THE PHOTOS CONFIRM A COMPRESSED SEGMENT IN THE CATHETER AT APPROXIMATELY 45MM FROM THE DISTAL TIP. A VERY PRONOUNCED KINK IS ALSO VISIBLE IN THE PICTURES, LOCATED AT THE PROXIMAL END, NEXT TO THE STRAIN RELIEF SLEEVE. THE COMPLAINT REGARDING A KINKED CATHETER WAS CONFIRMED BASED ON THE CONDITIONS OBSERVED IN THE PHOTOS. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31275832) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CEREGLIDE71 INTERMEDIATE CATHETER AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. IT IS IMPORTANT TO NOTE, THE DEVICE WAS NOT USED ACCORDING TO THE IFU; PER THE IFU, TO PREVENT THROMBUS FORMATION AND CONTRAST MEDIA CRYSTAL FORMATION, MAINTAIN A CONSTANT INFUSION OF APPROPRIATE FLUSH SOLUTION THROUGH CATHETER LUMEN. ACCORDING TO THE EVENT DESCRIPTION, THE CEREGLIDE71 CATHETER WAS USED FOR THE FIRST RETRIEVAL ATTEMPT AT THE INTERNAL CAROTID ARTERY (ICA), AFTER WHICH, ¿RESIDUAL THROMBUS WAS FOUND AT M1 [M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY].¿ SINCE THE THROMBOEMBOLISM OCCURRED WHILE THE CEREGLIDE71 WAS IN USE, THE CORRELATING RELATIONSHIP BETWEEN EVENT TO THE CEREGLIDE71 DEVICE CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, A SECOND RETRIEVAL ATTEMPT WAS REQUIRED (USING THE EMBOTRAP DEVICE) TO PRECLUDE PATIENT HARM. BASED ON THIS INFORMATION, THE EVENT OF A ¿THROMBOEMBOLISM¿ 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. 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 REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 12-AUG-2024. THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE CEREGLIDE 71 INTERMEDIATE CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. ONE KINK WAS OBSERVED NEXT TO THE ID BAND AT THE PROXIMAL END OF THE CATHETER. THERE WAS ONE COMPRESSED AREA OBSERVED AT THE TIP OF THE CATHETER AT 4.5 CM FROM THE DISTAL END. THE PRESENCE OF THE HYDROPHILIC COATING WAS CONFIRMED. NO DAMAGES WERE NOTED ON THE MESH OF THE TIP. THE CATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE, AND A LEAK WAS OBSERVED FROM THE OBSERVED KINK AT THE PROXIMAL END. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION A FRACTURE WAS NOTED DUE TO THE SEVERITY OF THE KINK. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31275832) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCE'S RELATED TO DEVICE MANUFACTURE OR INSPECTION. THE ISSUE REPORTED IN THE COMPLAINT REGARDING THE CATHETER BEING KINKED AT THE PROXIMAL END WAS CONFIRMED BASED ON THE DAMAGES MENTIONED ABOVE. HOWEVER, FACTORS NOT DESCRIBED IN THE INFORMATION PROVIDED, SUCH AS PATIENT¿S ANATOMY, DEVICE MANIPULATION, AND OPERATOR¿S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED. ACCORDING TO THE RISK DOCUMENTATION, A CATHETER BEING DAMAGED IS A POTENTIAL FAILURE THAT CAN APPEAR DURING DEVICE WITHDRAWAL DUE TO ANATOMICAL TORTUOSITY. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. THE COMPRESSED CONDITION NOTED ON THE TIP OF THE CATHETER WAS NOT ORIGINALLY REPORTED; THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED AND NO DAMAGES WERE NOTED SURROUNDING THE COMPRESSED CONDITION, THEREFORE, THIS IS NOT CONSIDER RELATED TO THE ISSUE REPORTED. 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 SUCH AS CATHETER STRETCHING AND KINKING FROM LEAVING THE FACILITY. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING CAUTIONS: DO NOT ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE DEVICE AGAINST RESISTANCE COULD DISLODGE A CLOT, PERFORATE A VESSEL WALL, OR DAMAGE THE DEVICE. 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. UPDATED SECTIONS. 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 29-JUL-2024. [ADDITIONAL INFORMATION]: ON 29-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE THROMBUS DID BREAK UP. THE PHYSICIAN COMMENTED THAT, ¿IT IS LIKELY THAT RESIDUAL THROMBUS IN [THE] M1 FLEW INTO THE ACA.¿ THERE WAS NO MALFUNCTION OR DEVICE PERFORMANCE ISSUE ASSOCIATED WITH THE EMBOTRAP III DEVICE. NO OTHER INFORMATION CAN BE OBTAINED. 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 MECHANICAL THROMBECTOMY PROCEDURE TARGETING A MIDDLE CEREBRAL ARTERY (MCA) INFARCTION, THERE WAS A MASSIVE THROMBUS AT THE INTERNAL CAROTID ARTERY (ICA), THE CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / 31275832) WAS INSERTED INTO AN OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL PRODUCTS), AND THE FIRST PASS WAS PERFORMED VIA ADAPT ((DIRECT ASPIRATION FIRST PASS TECHNIQUE). IT WAS REPORTED THAT RESIDUAL THROMBUS WAS FOUND AT THE M1 SEGMENT OF THE MCA AND THUS, A SECOND PASS WAS MADE WITH AN EMBOTRAP REVASCULARIZATION DEVICE (CATALOG / LOT# UNKNOWN) TO RETRIEVE THE RESIDUAL THROMBUS. AFTER THE SECOND PASS, THE ANTERIOR CEREBRAL ARTERY (ACA) WAS FOUND TO BE OCCLUDED. A THIRD PASS WAS ATTEMPTED WITH THE CEREGLIDE 71 INTERMEDIATE CATHETER, BUT A KINK WAS FOUND AT THE PROXIMAL PART OF THE CEREGLIDE CATHETER. ASPIRATION WITH THE CEREGLIDE 71 CATHETER WAS POSSIBLE AND THE PROCEDURE WAS REPORTED COMPLETED NO PROBLEMS. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED. OTHER CONCOMITANT PRODUCTS USED WERE A CHIKAI BLACK¿ NEURO GUIDEWIRE (ASAHI INTECC) AND A PHENOM¿ MICROCATHETER (MEDTRONIC). THERE WAS NO IMPACT TO THE PATIENT. ON 17-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE LOT NUMBER OF THE CEREGLIDE INTERMEDIATE CATHETER TO BE 31275832. THE CATALOG AND LOT NUMBER OF THE EMBOTRAP III REVASCULARIZATION DEVICE IS ET309537 / 23F156AV. THE SECOND PASS WAS MADE WITH BOTH THE EMBOTRAP III DEVICE AND THE CEREGLIDE INTERMEDIATE CATHETER TO RETRIEVE THE RESIDUAL THROMBUS AT THE M1 SEGMENT. THE TARGET LESION WAS IN THE MIDDLE CEREBRAL ARTERY (MCA). THE OCCLUSION IN THE ANTERIOR CEREBRAL ARTERY ¿SEEMED TO BE A DISTAL THROMBOEMBOLISM.¿ PER THE INFORMATION, THE CEREGLIDE INTERMEDIATE CATHETER WAS STILL USED FOR ASPIRATION EVEN WITH THE KINK FOUND AT THE PROXIMAL PART. THE ADDITIONAL INFORMATION ALSO CONFIRMED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 22-JUL-2024, PRE-SHIPMENT PHOTOS OF THE CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C) WERE ADDED TO THE COMPLAINT FILE. THE PHOTOS WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533781 132CM CEREGLIDE 71 CATHETER CATHETER, THROMBUS RETRIEVER NRY CERENOVUS, INC. 31275832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CHIKAI BLACK¿ NEURO GUIDEWIRE (ASAHI INTECC)| EMBOTRAP III 5 MM X 37 MM| OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL)| PHENOM¿ MICROCATHETER (MEDTRONIC)