BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 15526045 · Received October 1, 2022

    Report

    Report Number
    3008114965-2022-00613
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080251
    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). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / K10166) WAS THE THIRD COIL USED. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR 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 COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 1.00MM X 4.00CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE EMBOLIC COIL COMPONENT WAS OBSERVED PROTRUDING FROM THE INTRODUCER. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL COMPONENT WAS OBSERVED TO BE IN GOOD CONDITION (I.E., NO STRETCHED CONDITION, NO ELONGATION); IT WAS ALSO OBSERVED TO BE PARTIALLY INSIDE THE INTRODUCER. THE INTRODUCER COMPONENT WAS INSPECTED AND A KINK WAS NOTED AT THE POINT WHERE THE EMBOLIC COIL IS PROTRUDING FROM. THE REPORTED IMPEDED CONDITION OF THE COIL IN THE MICROCATHETER AS REPORTED IN THE COMPLAINT COULD NOT BE TESTED SINCE THE CONDITION OF THE RETURNED COMPLAINT DEVICE HAS THE COIL PROTRUDING FROM THE INTRODUCER; THIS PREVENTS THE COIL FROM BEING ADVANCED AND RETRACTED THROUGH THE INTRODUCER. THE REPORTED ISSUE RELATED TO THE EMBOLIC COIL IN STRETCHED CONDITION WAS NOT CONFIRMED. THE EMBOLIC COIL WAS INSPECTED UNDER THE MICROSCOPE AND WAS NOTED TO BE IN GOOD CONDITION WITHOUT ANY IDENTIFIABLE DEFECTS. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE APPEARANCE OF THE RETURNED DEVICE DOES NOT SUGGEST THAT IT WAS SUBJECTED TO EXCESSIVE FORCE TO OVERCOME THE FRICTION WITH THE MICROCATHETER. THERE IS NO INDICATION THAT THE ISSUE REPORTED RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10166) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTIONS: 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. 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. H.6: THE CODE ¿NO DEVICE PROBLEM FOUND (C19)¿ WAS USED IN THE INVESTIGATION FINDINGS BECAUSE THE ISSUE REPORTED RELATED TO THE COIL BEING STRETCHED WAS NOT CONFIRMED. THIS CODE CORRESPONDS WITH THE ¿NO PROBLEM DETECTED (D14)¿ IN THE INVESTIGATION CONCLUSION. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 20-OCT-2022.THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.10. 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.

    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 INITIAL REPORTER NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / 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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10166) 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / K10166) WAS THE THIRD COIL USED. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647259 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 K10166 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown