BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 13715391 · Received March 9, 2022

    Report

    Report Number
    3008114965-2022-00182
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 9, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080312
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL DELIVERY PUSHER WIRE ON THE 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / K10495) BECAME KINKED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT FILE. THE PRODUCT ANALYSIS LAB REVIEWED THE PHOTO. [PHOTO ANALYSIS]: A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED WITH THE COMPLAINT. BASED ON THE PHOTO, IT CAN BE OBSERVED THAT THE CORE WIRE OF THE 2.00MM X 6.00CM GALAXY G3 MINI COIL IS KINKED. NO OTHER DEFECTS WERE NOTED. THE REPORTED ISSUE THAT THE DELIVERY PUSHER WIRE (DEVICE POSITIONING UNIT (DPU) / THERMO-MECHANICAL DETACHMENT SYSTEM) WAS KINKED HAS BEEN CONFIRMED AS THE PHOTO SHOWED A KINKED DPU. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10495) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE MANUFACTURING RECORD EVALUATION REVIEW WAS PERFORMED. THERE IS NO INDICATED THAT THE REPORTED ISSUE IS RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 2.00MM X 6.00CM GALAXY G3 MINI COIL WAS RECEIVED AND VISUAL INSPECTION WAS PERFORMED. THE CORE WIRE IS NOTED TO BE KINKED AT 50.5 INCHES FROM THE PROXIMAL END. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL IS OBSERVED TO BE SEVERELY STRETCHED INSIDE THE INTRODUCER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE EMBOLIC COIL IN SEVERELY STRETCHED CONDITION. BASED ON THE VISUAL INSPECTION IN WHICH THE CORE WIRE WAS OBSERVED KINKED AT 50.5 INCHES FROM THE PROXIMAL END, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT IS CONFIRMED. THIS OBSERVATION IS ALSO CONSISTENT WITH THE PHOTO OF THE DEVICE WHICH SHOWED A KINKED CORE WIRE. THE STRETCHED CONDITION OF THE COIL IS NOT CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE REPORTED ISSUE; HOWEVER, IT MAY HAVE OCCURRED DURING THE REMOVAL OF THE COMPLAINT DEVICE OR DURING POST-PROCEDURE HANDLING. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING PRECAUTIONS: IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE MAIN ROTATING HEMOSTASIS VALVE (RHV), AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE, FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. DO NOT FASTEN THE RHV VALVE TOO TIGHTLY AROUND THE INTRODUCER SHEATH SINCE EXCESSIVE PRESSURE MAY CAUSE DAMAGE TO THE INTRODUCER SHEATH AND/OR THE MICROCOIL AS IT IS ADVANCED INTO THE INFUSION MICROCATHETER. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. STRETCHING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THE STRETCHED CONDITION OF THE EMBOLIC COIL WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED STRETCHED CONDITION OF THE EMBOLIC COIL COMPONENT CANNOT BE CONCLUSIVELY DETERMINED. ATTEMPTS WERE MADE TO OBTAIN INFORMATION RELATED TO THE PROCEDURE, TO THE REPORTED DEVICE ISSUE DID NOT YIELD ANY RESPONSE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 2.00MM X 6.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN STRETCHED CONDITION AS OBSERVED UNDER MAGNIFICATION DURING THE MICROSCOPIC INSPECTION. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL DELIVERY PUSHER WIRE ON THE 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / K10495) BECAME KINKED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT FILE. THE PRODUCT ANALYSIS LAB REVIEWED THE PHOTO. THE REVIEW IS INCLUDED IN THE PRODUCT INVESTIGATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 2.00MM X 6.00CM GALAXY G3 MINI COIL, THE EMBOLIC COIL WAS OBSERVED IN SEVERELY STRETCHED CONDITION INSIDE THE INTRODUCER. BASED ON THE PRODUCT ANALYSIS ON 09-MAR-2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784580 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 K10495 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown