BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS NIMBUS GCE

    MDR report key: 14674384 · Received June 13, 2022

    Report

    Report Number
    3011370111-2022-00056
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 1, 2025
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    PMA / PMN Number
    K212177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE OUTER CAGE WAS FOUND KINKED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING TREATMENT OF MIDDLE CEREBRAL ARTERY (M1 SEGMENT), THE OPERATOR FIRST FELT RESISTANCE WHEN INTRODUCING THE NIMBUS GSE (GCE4528, 21MO23AV) THROUGH THE RHV INTO THE HEADWAY21 HUB. NO PATIENT INJURY WAS REPORTED. THE INITIAL EXAMINATION OF THE RETURNED NIMBUS DEVICE DID NOT IDENTIFY ANY SIGNIFICANT DAMAGE OR DEFORMATION OF THE DEVICE. WHEN INSPECTED UNDER MAGNIFICATION, KINKING OF ONE OF THE PROXIMAL STRUTS WAS OBSERVED. THIS DAMAGE IS CONSISTENT WITH ADVANCEMENT OF THE DEVICE AGAINST RESISTANCE. NO FURTHER DAMAGE OR DEFORMATION OF THE DEVICE WAS NOTED. THE VISUAL INSPECTION ALSO INDICATES THAT THE RETURNED NIMBUS DEVICE WAS CORRECTLY ASSEMBLED AND MANUFACTURED, WITH ALL ADHESIVE BONDS AND JOINTS OTHER THAN THE PROXIMAL JOINT FULLY INTACT AND UNDAMAGED. THE RETURNED NIMBUS DEVICE WAS SUCCESSFULLY PASSED THROUGH A 0.0195¿ TUBE, CONFIRMING THAT THE PROFILE OF THE RETURNED DEVICE CONFORMED TO THE SPECIFICATION FOR COMPATIBILITY WITH 0.021¿ MICROCATHETERS. DEVICE INSERTION AND DELIVERY ASSESSMENTS WERE PERFORMED USING THE RETURNED NIMBUS DEVICE AND A SAMPLE HEADWAY 21 MICROCATHETER. THE MAJORITY OF THE DEVICE DELIVERED SUCCESSFULLY, WITH RESISTANCE EXPERIENCED AS THE SECTION IMMEDIATELY DISTAL OF THE PROXIMAL JOINT OF THE DEVICE WAS BEING DELIVERED. AT THIS POINT KINKING OF THE PROXIMAL STRUTS OF THE DEVICE WAS OBSERVED AT THE SAME LOCATION WHERE KINKING WAS OBSERVED OF THE DEVICE DURING VISUAL EXAMINATION IN FREE AIR. THE DEVICE FAILED TO DELIVER BEYOND THIS POINT, CONFIRMING THE COMPLAINT EVENT. A SAMPLE NIMBUS DEVICE WAS SUCCESSFULLY DELIVERED WITH THE SAME SAMPLE HEADWAY 21 MICROCATHETER, INDICATING THAT FAILURE OF THE RETURNED DEVICE TO DELIVER IN THE MICROCATHETER HUB WAS A RESULT OF THE DAMAGE PRESENT ON THE RETURNED NIMBUS DEVICE (I.E. KINKING OF THE PROXIMAL STRUTS). RECREATION OF THE DAMAGE OBSERVED ON THE RETURNED NIMBUS DEVICE WAS ACHIEVED THROUGH DELIVERY ASSESSMENTS WITH AN UNDAMAGED SAMPLE NIMBUS AND SAMPLE HEADWAY 21 MICROCATHETER. THE SAMPLE NIMBUS DEVICE WAS ATTEMPTED TO BE DELIVERED IN A SAMPLE HEADWAY 21 MICROCATHETER WITH THE INSERTION TOOL OF THE NIMBUS DEVICE SEATED AT INCREASING DISTANCES FROM THE MICROCATHETER LUMEN. THE SAMPLE NIMBUS DEVICE FAILED TO DELIVER WHEN THE INSERTION TOOL WAS SEATED 8MM FROM THE MICROCATHETER LUMEN AND KINKING OF THE PROXIMAL STRUTS OF THE DEVICE WAS OBSERVED DURING ATTEMPTED DELIVERY. THE RETURNED NIMBUS DEVICE EXHIBITS CHARACTERISTICS WHICH ARE CONSISTENT WITH ADVANCEMENT OF THE DEVICE AGAINST RESISTANCE. VISUAL INSPECTION OF THE DEVICE SHOWED EVIDENCE OF KINKING OF THE PROXIMAL SECTION OF THE DEVICE. VISUAL INSPECTION OF THE MICROCATHETER USED DURING THE COMPLAINT EVENT COULD NOT BE CARRIED OUT AS THIS WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE INVESTIGATION CARRIED OUT WITH THE RETURNED NIMBUS, SAMPLE HEADWAY 21 MICROCATHETER AND A SAMPLE NIMBUS, IT IS DETERMINED THAT A PROBABLE ROOT CAUSE OF THE COMPLAINT EVENT WAS FAILURE TO DELIVER THE NIMBUS DUE TO POOR SEATING OF THE INSERTION TOOL DURING THE INITIAL DELIVERY ATTEMPT. AS DEMONSTRATED, POOR SEATING OF THE INSERTION TOOL CAN LEAD TO FAILURE OF THE DEVICE TO DELIVER IN THE MICROCATHETER HUB. DELIVERY OF THE DEVICE MEETS RESISTANCE AND KINKING OF THE PROXIMAL STRUTS OF THE DEVICE OCCURS IF ATTEMPTS TO DELIVER ARE CONTINUED. PERMANENT DEFORMATION IN THE FORM OF KINKING OF THE PROXIMAL STRUTS WAS OBSERVED ON THE RETURNED DEVICE WHEN VISUALLY INSPECTED, AND ALSO WERE OBSERVED TO BE CONTRIBUTING TO FAILURE OF THE RETURNED DEVICE TO DELIVER IN A SAMPLE HEADWAY 21 MICROCATHETER. TWO POSSIBLE CAUSES OF THE INSERTION TOOL NOT BEING SEATED FULLY ARE: ¿ THE INSERTION TOOL WAS NOT FULLY SEATED INITIALLY (I.E. NOT SEATED AS CLOSE TO THE MICROCATHETER LUMEN AS POSSIBLE (1-2MM)) ¿ THE INSERTION TOOL WAS NOT SECURED IN PLACE USING THE RHV, ALLOWING MOVEMENT OF THE INSERTION TOOL DURING DELIVERY OF THE NIMBUS DEVICE. THE COMPLAINT EVENT WAS CONFIRMED USING THE RETURNED NIMBUS DEVICE AND A SAMPLE HEADWAY 21 MICROCATHETER. AN UNDAMAGED SAMPLE NIMBUS WAS SUCCESSFULLY DELIVERED THROUGH THE SAME SAMPLE HEADWAY 21 MICROCATHETER, INDICATING THAT THE DAMAGE PRESENT ON THE RETURNED NIMBUS DEVICE IS THE CAUSE OF THE RETURNED DEVICE FAILING TO DELIVER IN A MICROCATHETER. THERE IS NO INDICATION THAT THIS COMPLAINT WAS AS A RESULT OF A DEFECT WITH THE NIMBUS DEVICE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF #: (B)(4). PLEASE NOTE THAT MEDWATCH REPORT MWR (B)(4) WAS SUBMITTED INCORRECTLY. THE GEOMETRIC CLOT EXTRACTOR (GCE) HAS NOT BEEN APPROVED BY THE US FDA AND IS NOT MARKETED IN THE US; THEREFORE, THIS COMPLAINT DOES NOT MEET USFDA REPORTING CRITERIA AND IS NOT MDR REPORTABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING TREATMENT OF THE MIDDLE CEREBRAL ARTERY (M1 SEGMENT), THE OPERATOR FIRST FELT RESISTANCE WHEN INTRODUCING THE NIMBUS GSE (GCE4528, 21MO23AV) THROUGH THE RHV INTO THE HEADWAY21 HUB. NO PATIENT INJURY WAS REPORTED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE OUTER CAGE WAS FOUND KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688330 CERENOVUS NIMBUS GCE CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEADWAY 21 MICROCATHETER