BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 3.5MM X 5CM

    MDR report key: 8696227 · Received June 13, 2019

    Report

    Report Number
    3008114965-2019-01051
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077657
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). BASED ON ADDITIONAL INFORMATION RECEIVED, SECTION E1 WAS CORRECTED. THE SALES REPRESENTATIVE PROVIDED THE WRONG HOSPITAL NAME INITIALLY. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A LEFT OPHTHALMIC ANEURYSM (3X4MM), THERE WAS DIFFICULTY PLACING TWO GALAXY G3 COILS. THE MICROCATHETER USED WAS AN SL10. THE USER ENTERED INTO THE ANEURYSM WITHOUT DIFFICULTY. THE FIRST GALAXY G3 COIL (GLX123505, L10142) CONFORMED WELL WITHIN THE ANEURYSM UNTIL THE LAST COIL LOOP, THE LAST LOOP DEPLOYED. IT PUSHED THE MICRO CATHETER OUT OF THE ANEURYSM. AFTER TRYING 3 TIMES, THE COIL WAS REMOVED AND REPLACED WITH A NON-CERENOVUS 3.5 X8 XTRA SOFT COIL WITHOUT ANY ISSUE. THEN ANOTHER NON-CERENOVUS 2X6CM COIL WAS PLACED WITHOUT ANY ISSUE. THE NEXT COIL WAS A GALAXY G3 MINI (GLM915025, UNKNOWN LOT). THE COIL WENT IN FINE UNTIL THE LAST LOOP AND KICKED THE MICROCATHETER BACK. THE USER TRIED 3 -4 TIMES AND REMOVED THE COIL. A NON-CERENOVUS COIL WAS PLACED IN WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS SURGERY DELAY DUE TO THE EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE WAS DISCARDED AND THEREFORE IS NOT AVAILABLE FOR INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L10142 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿COIL - POSITIONING DIFFICULTY-POOR CONFORMABILITY¿ COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE WERE UNSUCCESSFUL. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS ON PROPER POSITIONING OF THE MICROCOIL SYSTEM. THE IFU ALSO WARNS: ¿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. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PROCODE: KRD/HCG. CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS IS 3008114965-2019-01052. 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 · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A LEFT OPHTHALMIC ANEURYSM (3X4MM), THERE WAS DIFFICULTY PLACING TWO GALAXY G3 COILS. THE MICROCATHETER USED WAS AN SL10. THE USER ENTERED INTO THE ANEURYSM WITHOUT DIFFICULTY. THE FIRST GALAXY G3 COIL (GLX123505, L10142) CONFORMED WELL WITHIN THE ANEURYSM UNTIL THE LAST COIL LOOP, THE LAST LOOP DEPLOYED. IT PUSHED THE MICRO CATHETER OUT OF THE ANEURYSM. AFTER TRYING 3 TIMES, THE COIL WAS REMOVED AND REPLACED WITH A NON-CERENOVUS 3.5 X8 XTRA SOFT COIL WITHOUT ANY ISSUE. THEN ANOTHER NON-CERENOVUS 2X6CM COIL WAS PLACED WITHOUT ANY ISSUE. THE NEXT COIL WAS A GALAXY G3 MINI (GLM915025, UNKNOWN LOT). THE COIL WENT IN FINE UNTIL THE LAST LOOP AND KICKED THE MICROCATHETER BACK. THE USER TRIED 3 -4 TIMES AND REMOVED THE COIL. A NON-CERENOVUS COIL WAS PLACED IN WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS SURGERY DELAY DUE TO THE EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489762 GALAXY G3 XSFT 3.5MM X 5CM GALAXY G3 KRD MEDOS INTERNATIONAL SARL L10142 10886704077657

    Patients

    Seq Age Sex Outcome Treatment
    1 SL10 MICROCATHETER