BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19660075 · Received July 2, 2024

    Report

    Report Number
    3007628272-2024-00035
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 12, 2024
    Report Date
    August 26, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, AND MEDICAL HISTORY WAS NOT REPORTED. DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. 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 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). SECTION D2B: PROCODE IS NRY/QJP. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M1 OCCLUSION FOR ACUTE ISCHEMIC STROKE. THE 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31281884) WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). TOTAL 5 PASSES WERE MADE BY COMBINED TECHNIQUE WITH USING A SOLITAIRE, TRAK21 MICROCATHETER (MC) AND THE CEREGLIDE 71, THEN ACHIEVED RECANALIZATION. AT COMPLETION OF THE PROCEDURE, THE CEREGLIDE 71 WAS FOUND TO BE DAMAGED AFTER WITHDRAWING FROM THE PATIENT¿S BODY. WHEN FLUSHING THE CATHETER OUTSIDE OF THE PATIENT, A LEAK OF NORMAL SALINE SOLUTION WAS FOUND AT 4-5CM FROM THE CATHETER TIP. THE CATHETER WAS THOUGHT TO HAVE A HOLE, WHICH WAS SUSPECTED TO BE LED BY A KINK. THE PROCEDURE ITSELF WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JUN-2024 AND ON 24-JUN-2024 INDICATING THAT THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. THE DEVICE WAS NOT ADVANCED OR WITHDRAWN AGAINST RESISTANCE. A NON-STERILE 132CM CEREGLIDE 71 CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND ONE (1) COMPRESSED CONDITION WAS NOTED AT 5CM FROM THE DISTAL END OF THE CATHETER. THE INTERNAL COATING OF THE TIP WAS NOTED TO BE DELAMINATED, AND THE MESH OF THE TIP WAS SLIGHTLY STRETCHED. THE CATHETER WAS FLUSHED USING A LAB-SAMPLE SYRINGE, AND THE WATER WAS LEAKING AT 4.5 CM FROM THE DISTAL END. THE DISTAL TIP WAS INSPECTED UNDER MAGNIFICATION AND A CUT WAS NOTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUES REPORTED REGARDING A CUT AND KINKED CONDITIONS ON THE DISTAL TIP OF THE CATHETER WERE CONFIRMED BASED ON THE DAMAGES FOUND; 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 DAMAGED CATHETER IS A POTENTIAL ISSUE THAT CAN OCCUR DURING WITHDRAWAL OF CATHETER. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED, HOWEVER, GIVEN THE BROAD SEQUENCE OF EVENTS, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS RELATED TO A MANUFACTURING ISSUE. THE DELAMINATION OF THE INTERNAL COATING OF THE TIP WAS NOT ORIGINALLY REPORTED; THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED. IT IS SUGGESTED THAT THIS CONDITION COULD BE THE RESULT OF THE POST-HANDLING OF THE DEVICE; 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. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: EXERCISE CARE IN HANDLING THE INTERMEDIATE CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. 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, THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M1 OCCLUSION FOR ACUTE ISCHEMIC STROKE. THE 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31281884) WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). TOTAL 5 PASSES WERE MADE BY COMBINED TECHNIQUE WITH USING A SOLITAIRE, TRAK21 MICROCATHETER (MC) AND THE CEREGLIDE 71, THEN ACHIEVED RECANALIZATION. AT COMPLETION OF THE PROCEDURE, THE CEREGLIDE 71 WAS FOUND TO BE DAMAGED AFTER WITHDRAWING FROM THE PATIENT¿S BODY. WHEN FLUSHING THE CATHETER OUTSIDE OF THE PATIENT, A LEAK OF NORMAL SALINE SOLUTION WAS FOUND AT 4-5CM FROM THE CATHETER TIP. THE CATHETER WAS THOUGHT TO HAVE A HOLE, WHICH WAS SUSPECTED TO BE LED BY A KINK. THE PROCEDURE ITSELF WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JUN-2024 AND ON 24-JUN-2024 INDICATING THAT THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO THE PATIENT DUE TO THE LEAKAGE. THE DEVICE WAS NOT ADVANCED OR WITHDRAWN AGAINST RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821525 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY CERENOVUS, INC. 31281884 10886704085393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown