BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1.5MM X 4CM

    MDR report key: 15562115 · Received October 7, 2022

    Report

    Report Number
    3008114965-2022-00643
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    August 16, 2022
    Report Date
    October 10, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080152
    PMA / PMN Number
    K171862
    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). THE CORRECT DEVICE MANUFACTURED DATE IS 12/13/2021.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS FOUND KINKED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE: 03-3269-8111. 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. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, A GUIDING CATHETER, AN UNSPECIFIED DISTAL ASSESS CATHETER (DAC) AND A EXSELSIOR SL10 MICROCATHETER (MC) APPROACHED TO THE LESION. A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040, 30704818) WAS USED AS THE FIFTH COIL AFTER FOUR J&J COILS WERE IMPLANTED. THE 1.5MM X 4CM GALAXY G3 MINI COIL WAS TRIED TO BE USED IN THE SAME WAY AS THE PREVIOUS FOUR COILS. HOWEVER, THERE WAS RESISTANCE FELT IN THE MICROCATHETER AND THE COMPLAINT COIL WAS UNABLE TO BE INSERTED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED WITH SEVEN J&J COILS. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THE STATUS OF THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THEY WERE NO ABLE TO MOVE THE DEVICE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. A NON-STERILE GALAXY G3 MINI 1.5MM X 4CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE INTRODUCER WAS NOT RETURNED WITH THE DEVICE. NO DAMAGES WERE FOUND IN THE DEVICE. THE DEVICE WAS INSPECTED UNDER MAGNIFICATION, AND IT WAS FOUND THAT THE COIL WAS STRETCHED, AND MULTIPLE KINKED CONDITIONS WERE FOUND ON IT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30704818 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE CONDITIONS DESCRIBED ABOVE PRECLUDED PROPER FUNCTIONAL TESTING, HOWEVER, THE CUSTOMER COMPLAINT REGARDING RESISTANCE WITH THE MICROCATHETER WAS CONFIRMED BASED ON THE APPEARANCE OF THE RETURNED COIL. COIL KINKING AND STRETCHING ARE KNOWN POTENTIAL ISSUES ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUES FROM OCCURRING. IT IS POSSIBLE THAT CONTINUOUS FLUSH HAD NOT BEEN DONE, WITHOUT AN ADEQUATE FLUSH, ISSUES SUCH AS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER CAN ARISE. THE KINKED AND STRETCHED CONDITIONS CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THE COMPLAINT DOCUMENTED THAT THE COIL COULD NOT BE ADVANCED THROUGH FROM THE CONCOMITANT MICROCATHETER. IT IS POSSIBLE THAT FORCE MAY HAVE INADVERTENTLY BEEN APPLIED DURING THE COIL ADVANCEMENT IN AN ATTEMPT TO OVERCOME THE RESISTANCE, WHICH RESULTED IN THE COIL DAMAGE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RE-SHEATHING TOOL APPROXIMATELY 1 IN. ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. AFTER FLUSHING, REINSERT THE INTRODUCER INTO THE INFUSION CATHETER HUB. ¿ IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, A GUIDING CATHETER, AN UNSPECIFIED DISTAL ASSESS CATHETER (DAC) AND A EXSELSIOR SL10 MICROCATHETER (MC) APPROACHED TO THE LESION. A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040, 30704818) WAS USED AS THE FIFTH COIL AFTER FOUR J&J COILS WERE IMPLANTED. THE 1.5MM X 4CM GALAXY G3 MINI COIL WAS TRIED TO BE USED IN THE SAME WAY AS THE PREVIOUS FOUR COILS. HOWEVER, THERE WAS RESISTANCE FELT IN THE MICROCATHETER AND THE COMPLAINT COIL WAS UNABLE TO BE INSERTED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED WITH SEVEN J&J COILS. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THE STATUS OF THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THEY WERE NO ABLE TO MOVE THE DEVICE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS STRETCHED AND WITH MULTIPLE KINK CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592392 GALAXY G3 MINI 1.5MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM915040 30704818 10886704080152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EXSELSIOR SL10 MICROCATHETER.| UNSPECIFIED DISTAL ASSESS CATHETER.| UNSPECIFIED GUIDING CATHETER.