BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 11693251 · Received April 20, 2021

    Report

    Report Number
    3008114965-2021-00160
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 4, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080251
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH REPORT: D9, G3, H6, H2, H3, H6 AND H10. 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 A COIL EMBOLIZATION AT THE WIDE-NECK (7MM) OF THE BASILIAR ARTERY (BA), A LVIS JR, TERUMO STENT, A TARGET COIL AND FOUR AXIUM PRIME COILS WERE IMPLANTED. AFTER THAT, A 1MM X 4CM GALAXY G3 MINI (GLM910040, LOT UNKNOWN) WAS USED AS THE FINISHING COIL AND IMPLANTED. A 1MM X 3CM GALAXY G3 MINI (GLM910030, L14400) WAS INSERTED INTO A PHENOM 17, MEDTRONIC MICROCATHETER (MC) BUT THERE WAS A RESISTANCE FELT BETWEEN THE HUB PART AND THE COMPLAINT COIL. THE PHYSICIAN ATTEMPTED TO CONFIRM THE SITUATION, SO THE COMPLAINT COIL WAS RE-SHEATHED FROM THE DEPLOYMENT SHEATH OUTSIDE THE PATIENT, BUT THE COMPLAINT COIL WAS NOT ABLE TO COME OUT FROM THE DISTAL END DUE TO THE RESISTANCE. IT WAS REPLACED WITH A 1MM X 4CM GALAXY G3 MINI (GLM910040, K10748) AND A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, 30412526) BUT THE SAME ISSUE OCCURRED. AN ED COIL WAS ADDED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED AND NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON VISUAL ANALYSIS OF THE PHOTOS PROVIDED OF THE GALAXY G3 MINI 1MM X 4CM, IT CAN BE DETERMINED THAT THE EMBOLIC COIL HAS A KINKED CONDITION AND REMAINS ATTACHED TO THE RH. NO OTHER DAMAGES COULD BE NOTED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 30412526 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. A NON-STERILE UNIT GALAXY G3 MINI 1MM X 4CM WAS RETURNED TO CERENOVUS FOR EVALUATION INSIDE OF A POUCH. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD NORMAL CONDITIONS, NO DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. ALSO, THE MARKER BAND WAS FOUND AT 39 CM FROM THE HUB, WHICH IS WITHIN SPECIFICATION. THE EMBOLIC COIL WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND DAMAGED AND STUCK INSIDE THE INTRODUCER. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE DAMAGED AND STUCK CONDITIONS NOTED ON THE EMBOLIC COIL. BASED ON THE FINDINGS DURING THE PRODUCT ANALYSIS, THE CUSTOMER COMPLAINT OF ¿COIL ¿ RESISTANCE/FRICTION-WITH DELIVERY CATHETER ¿ NO LOSS OF CEREBRAL TARGET POSITION¿ WAS CONFIRMED. THE DAMAGED AND STUCK CONDITIONS NOTED ON THE EMBOLIC COIL ARE RELATED TO THE CUSTOMER COMPLAINT. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTIONS: ¿ 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 AS DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. ¿ 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. ¿ IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. DAMAGE TO THE EMBOLIC COIL CAN BE CAUSED BY THE APPLICATION OF EXCESSIVE FORCE TO A DEVICE WHILE TRYING TO ADVANCE AGAINST RESISTANCE. 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

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED KINKED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. BASED ON VISUAL ANALYSIS OF THE PHOTOS PROVIDED OF THE GALAXY G3 MINI 1MM X 4CM, IT CAN BE DETERMINED THAT THE EMBOLIC COIL HAS A KINKED CONDITION AND REMAINS ATTACHED TO THE RH. NO OTHER DAMAGES COULD BE NOTED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 30412526 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE REPORTED CONDITION ¿COIL RESISTANCE/FRICTION-WITH DELIVERY CATHETER - NO LOSS OF CEREBRAL TARGET POSITION¿ COULD NOT BE EVALUATED BASED ON THE PICTURES, HOWEVER, THE KINK NOTED ON THE COIL MAY CONTRIBUTE TO THE RESISTANCE/FRICTION FELT. THE MRE SUGGESTS THAT THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. FURTHER INVESTIGATION WILL BE PERFORMED ONCE THE DEVICE RETURNS FOR ANALYSIS. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2021-00158, 3008114965-2021-00159 AND 3008114965-2021-00160.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE WIDE-NECK (7MM) OF THE BASILIAR ARTERY (BA), A LVIS JR, TERUMO STENT, A TARGET COIL AND FOUR AXIUM PRIME COILS WERE IMPLANTED. AFTER THAT, A 1MM X 4CM GALAXY G3 MINI (GLM910040, LOT UNKNOWN WAS USED AS THE FINISHING COIL AND IMPLANTED. A 1MM X 3CM GALAXY G3 MINI (GLM910030, L14400) WAS INSERTED INTO A PHENOM 17, MEDTRONIC MICROCATHETER (MC) BUT THERE WAS A RESISTANCE FELT BETWEEN THE HUB PART AND THE COMPLAINT COIL. THE PHYSICIAN ATTEMPTED TO CONFIRM THE SITUATION, SO THE COMPLAINT COIL WAS RE-SHEATHED FROM THE DEPLOYMENT SHEATH OUTSIDE THE PATIENT, BUT THE COMPLAINT COIL WAS NOT ABLE TO COME OUT FROM THE DISTAL END DUE TO THE RESISTANCE. IT WAS REPLACED WITH A 1MM X 4CM GALAXY G3 MINI (GLM910040, K10748) AND A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, 30412526) BUT THE SAME ISSUE OCCURRED. AN ED COIL WAS ADDED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED AND NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE VISUAL ANALYSIS OF THE PICTURES RECEIVED FOR ALL THE THREE COMPLAINT COLS, THE EMBOLIC COIL OF THE GALAXY G3 MINI 1MM X 3CM AND THE GALAXY G3 MINI 1MM X 4CM HAS A KINK. THE EMBOLIC COIL OF THE GALAXY G3 MINI 1MM X 4CM, IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592139 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 30412526 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 GALAXY G3 MINI 1MM X 3CM.| GALAXY G3 MINI 1MM X 4CM.| PHENOM 17, MEDTORNIC MICROCATHETER.