BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19741275 · Received July 15, 2024

    Report

    Report Number
    3007628272-2024-00041
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 26, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION H3 - 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). . COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, THE HUB OF A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31275831) WAS LEAKING AND LOOSE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 15-JUL-2024 INDICATING THAT THE EVENT OCCURRED DURING THE PREPPING OF THE DEVICE. AS PER THEIR STANDARD PROCEDURE, THEY HAD PRE-LOADED A MICROCATHETER (HEADWAY 0.021¿). THEY NOTICED FLUID LEAKING FROM THE STRAIN RELIEF SECTION OF CATHETER. THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED, OR DAMAGED IN ANY OTHER WAY. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. ONE NON-STERILE 132CM CEREGLIDE 71 CATHETER WAS RETURNED IN THE DECONTAMINATION POUCH. UPON RECEIPT OF THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPARENT DAMAGE WAS NOTED. THE DEVICE WAS CONNECTED TO A LAB SAMPLE SYRINGE AND THEN WAS FLUSHED, WATER LEAKAGE WAS OBSERVED AT THE HUB SECTION. MICROSCOPIC EXAMINATION WAS PERFORMED. UNDER MAGNIFICATION, IT WAS NOTED THAT THE HUB HAD BEEN SUBJECTED TO FORCE, WHICH CAUSED THE OUTER PLASTIC LAYER TO FRACTURE, EXPOSING THE INTERNAL WIRES. THE ISSUE REPORTED THAT THE HUB LEAKAGE AND FEELING LOOSE WAS CONFIRMED DURING THE FUNCTIONAL TEST. HUB DAMAGE DURING ATTACHMENT/REMOVAL OF HEMOSTASIS VALVE IS A POTENTIAL FAILURE MODE THAT CAN RESULT FROM THE HANDLING OF HEMOSTASIS VALVE AND HUB, WHICH MAY RESULT IN EXCESSIVE FORCE APPLIED, CAUSING DEVICE DAMAGE. DEVICES UNDERGO 100% INSPECTION FOR EXPOSED WIRE INSIDE THE HUB DURING HUB INJECTION MOLDING PROCESS, AND 100% INSPECTION FOR CATHETER KINKS OR DAMAGES DURING CATHETER LOADING INTO HOOP. THUS, IT IS NOT LIKELY THAT THE DEVICE LEFT THE FACILITY IN A DAMAGED CONDITION; INTRA-OPERATIVE FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE REPORTED, HOWEVER, WITH THE AMOUNT OF INFORMATION AVAILABLE, A ROOT CAUSE CANNOT BE ESTABLISHED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31275831 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY IS REQUIRED. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO THE CAUSE OF THE EVENT REPORTED, THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTIONS: - BEFORE REMOVING THE INTERMEDIATE CATHETER FROM THE PACKAGING HOOP DISPENSER, ROTATE THE LUER ON THE PACKAGING HOOP 90 DEGREES. - GENTLY REMOVE THE CATHETER AND ACCESSORIES FROM THE HOOP AND INSPECT PRIOR TO USE TO VERIFY THAT THEY ARE UNDAMAGED. CAUTION: DO NOT USE A CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH ANOTHER LARGE BORE CATHETER THAT IS NOT DAMAGED. - 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 DAMAGE THE DEVICE OR CAUSE PATIENT INJURY. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, THE HUB OF A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31275831) WAS LEAKING AND LOOSE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 15-JUL-2024 INDICATING THAT THE EVENT OCCURRED DURING THE PREPPING OF THE DEVICE. AS PER THEIR STANDARD PROCEDURE, THEY HAD PRE-LOADED A MICROCATHETER (HEADWAY 0.021¿). THEY NOTICED FLUID LEAKING FROM THE STRAIN RELIEF SECTION OF CATHETER. THE DEVICE DID NOT APPEAR KINKED, COMPRESSED, CRACKED, OR DAMAGED IN ANY OTHER WAY. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286019 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY CERENOVUS, INC. 31275831 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEADWAY 0.021¿ MICROCATHETER