BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 3CM

    MDR report key: 10502711 · Received September 8, 2020

    Report

    Report Number
    3008114965-2020-00400
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 17, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080244
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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, A 1MM X 2CM GALAXY G3 MINI COIL (GLM910020, 30383036) AND A 1MM X 3CM GALAXY G3 MINI COIL (GLM910030, K10700) FAILED TO DETACH. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE UNIT GALAXY G3 MINI 1MM X 3CM WAS RECEIVED INSIDE OF A POUCH. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD NORMAL CONDITIONS, NO ANOMALIES OR DAMAGES WERE OBSERVED DURING THE VISUAL INSPECTION. ALSO, THE MARKER BAND WAS FOUND AT 38 CM FROM HUB, WHICH IS WITHIN SPECIFICATION. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND THE EMBOLIC COIL WAS FOUND WITH A KINKED/STRETCH CONDITION PROTRUDED FROM THE INTRODUCER. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE THE PROTRUDED CONDITION NOTED ON THE EMBOLIC COIL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30383036 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - FAILURE TO DETACH¿ COULD NOT BE EVALUATED, SINCE DURING THE ANALYSIS IT WAS NOTED THAT THE EMBOLIC COIL HAS A KINKED/STRETCH CONDITION, ALSO IT WAS PROTRUDED FROM THE INTRODUCER, DUE THIS CONDITION THE FUNCTIONAL TEST COULD NOT BE PERFORMED. THIS CONDITION COULD BE CONTRIBUTING TO THE COMPLAINT REPORTED BY THE CUSTOMER, SINCE THE EMBOLIC COIL NEEDS TO BE OUT OF THE INTRODUCER TO START THE DETACHMENT CYCLE, BASED ON THE INFORMATION OBTAINED DURING THE ANALYSIS THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE KINKED/STRETCH CONDITION NOTED ON THE EMBOLIC COIL MAY APPEAR 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 SUGGESTS THAT THE FAILURE REPORTED BY THE CUSTOMER 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. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF INFORMATION IS PROVIDED AT A LATER DATE, THE FILE WILL BE REOPENED AND PROCESSED ACCORDINGLY. 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

    PRODUCT COMPLAINT #: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. 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. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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 3008114965-2020-00399 AND 3008114965-2020-00400. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1MM X 2CM GALAXY G3 MINI COIL (GLM910020, 30383036) AND A 1MM X 3CM GALAXY G3 MINI COIL (GLM910030, K10700) FAILED TO DETACH. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968163 GALAXY G3 MINI 1MM X 3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910030 K10700 10886704080244

    Patients

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