BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1.5MM X 2CM

    MDR report key: 10074679 · Received May 20, 2020

    Report

    Report Number
    3008114965-2020-00176
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 29, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080138
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 3CM GALAXY G3 MINI COIL (GLM920030, K10170) AND A 1.5MM X 2CM GALAXY G3 MINI COIL (GLM915020, L16815) WERE BEING USED AS THE FIRST AND SECOND COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COILS, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING THE DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEMS. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. ONE NON-STERILE GALAXY G3 MINI 1.5MM X 2CM UNIT WAS RECEIVED INSIDE OF A POUCH. THE RECEIVED DEVICE WAS VISUALLY INSPECTED, AND NO DAMAGES WERE NOTED ON IT. THEN A MICROSCOPIC INSPECTION WAS PERFORMED, AND THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT BEEN HEATED AND THE DETACHMENT PROCESS WAS NOT INITIATED. THE EMBOLIC COIL WAS NOT RETURNED FOR EVALUATION AND IT COULD BE NOTED THAT IT WAS MECHANICALLY DETACHED FROM THE DEVICE. NO OTHER DAMAGES WERE OBSERVED. ALSO, THE MARKER BAND WAS FOUND AT 37CM FROM DISTAL END AND IT WAS FOUND WITHIN SPECIFICATION. THE RESISTANCE OF THE DEVICE WAS MEASURED WITH MULTIMETER AND A LAB SAMPLE ENPOWER CONTROL CABLE. RESISTANCE INITIALLY MEASURED APPROXIMATELY 54.2 O, WHICH IS IN OF THE SPECIFICATION RANGE. ALSO, THE RECEIVED UNIT GALAXY G3 MINI 1.5MM X 2CM WAS CONNECTED TO A LAB SAMPLE ENPOWER CONTROL CABLE AND THEY WERE CONNECTED TO DETACHMENT CONTROL BOX (DCB) AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT ILLUMINATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L16815 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - FAILURE TO DETACH¿ WAS NOT CONFIRMED BECAUSE THE DEVICE WAS FOUND WITHIN THE SPECIFICATIONS IN THE FUNCTIONAL TEST. THE MECHANICALLY DETACH CONDITION APPEARS TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE MRE SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES ON THE RETURNED SYSTEM. BASED ON THE DEVICE ANALYSIS, THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT BEEN HEATED AND THE DETACHMENT PROCESS WAS NOT INITIATED. 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 · 1

    (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2020-00177.

    Description of Event or Problem · 1

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 3CM GALAXY G3 MINI COIL (GLM920030, K10170) AND A 1.5MM X 2CM GALAXY G3 MINI COIL (GLM915020, L16815) WERE BEING USED AS THE FIRST AND SECOND COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COILS, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEMS. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541184 GALAXY G3 MINI 1.5MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM915020 L16815 10886704080138

    Patients

    Seq Age Sex Outcome Treatment
    1 GALAXY G3 MINI 2MM X 3CM.