BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 4MM X 12CM

    MDR report key: 15919425 · Received December 5, 2022

    Report

    Report Number
    3008114965-2022-00754
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 5, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077480
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). PROCODE IS KRD/HCG. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL WAS MADE AWARE OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2022, INVOLVING A 4MM X 12CM GALAXY G3 COIL (GLY120412 / K10710). THE PROCEDURE WAS TARGETING A LESION ON THE INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. AT THE TIME OF THE COMPLAINT INITIATION, LIMITED INFORMATION WAS AVAILABLE. ON (B)(6) 2022, THE CERENOVUS SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION. THE INFORMATION INDICATED THAT THE COMPLAINT COIL WAS USED FOR AN ABDOMINAL VISCERAL ANEURYSM. THE 4MM X 12CM GALAXY G3 COIL WAS USED AFTER ¿SOME GUIDING CATHETERS AND SOME MICROCATHETERS¿ WERE USED INSIDE THE ANEURYSM. THE COMPLAINT COIL WAS RE-SHEATHED BECAUSE IT WAS UNABLE TO BE IMPLANTED AS INTENDED. THE MICROCATHETER(S) WERE REPOSITIONED AND THE COMPLAINT COIL WAS INSERTED AND AN ATTEMPT TO IMPLANT WAS MADE, BUT IT SEEM TO BE ABOUT TO UNRAVEL. IT WAS REPORTED THAT ELECTRICAL CONTINUITY WAS CHECKED. IT WAS INSERTED BUT UNABLE TO BE IMPLANTED. DURING THE RE-SHEATHING ATTEMPT IN PREPARATION FOR RE-INSERTION, THE COIL SEEM ABOUT TO BE UNRAVELED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS NOT WITHDRAWN WITH THE MICROCATHETER; IT WAS ONLY THE MICROCATHETER THAT WAS REINSERTED AND REPOSITIONED. INFORMATION RELATED TO THE BRANDS OF THE CONCOMITANT MICROCATHETER AND GUIDING CATHETER USED COULD NOT BE OBTAINED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE INFORMATION INDICATED THAT ¿SOME COILS WERE USED PRIOR TO THIS COMPLAINT COIL¿ HOWEVER, THE QUANTITY OF COILS USED WAS NOT PROVIDED. THERE WAS NO KINK NOTED ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED CONDITION; THE COIL WAS PURPOSELY DETACHED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10710) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. COIL UNRAVELING / 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 ISSUES FROM OCCURRING. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. 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. 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 WAS MADE AWARE OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2022, INVOLVING A 4MM X 12CM GALAXY G3 COIL (GLY120412 / K10710). THE PROCEDURE WAS TARGETING A LESION ON THE INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. AT THE TIME OF THE COMPLAINT INITIATION, LIMITED INFORMATION WAS AVAILABLE. ON (B)(6) 2022 THE CERENOVUS SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION. THE INFORMATION INDICATED THAT THE COMPLAINT COIL WAS USED FOR AN ABDOMINAL VISCERAL ANEURYSM. THE 4MM X 12CM GALAXY G3 COIL WAS USED AFTER ¿SOME GUIDING CATHETERS AND SOME MICROCATHETERS¿ WERE USED INSIDE THE ANEURYSM. THE COMPLAINT COIL WAS RE-SHEATHED BECAUSE IT WAS UNABLE TO BE IMPLANTED AS INTENDED. THE MICROCATHETER(S) WERE REPOSITIONED AND THE COMPLAINT COIL WAS INSERTED AND AN ATTEMPT TO IMPLANT WAS MADE, BUT IT SEEM TO BE ABOUT TO UNRAVEL. IT WAS REPORTED THAT ELECTRICAL CONTINUITY WAS CHECKED. IT WAS INSERTED BUT UNABLE TO BE IMPLANTED. DURING THE RE-SHEATHING ATTEMPT IN PREPARATION FOR RE-INSERTION, THE COIL SEEM ABOUT TO BE UNRAVELED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 01-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS NOT WITHDRAWN WITH THE MICROCATHETER; IT WAS ONLY THE MICROCATHETER THAT WAS REINSERTED AND REPOSITIONED. INFORMATION RELATED TO THE BRANDS OF THE CONCOMITANT MICROCATHETER AND GUIDING CATHETER USED COULD NOT BE OBTAINED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE INFORMATION INDICATED THAT ¿SOME COILS WERE USED PRIOR TO THIS COMPLAINT COIL¿ HOWEVER, THE QUANTITY OF COILS USED WAS NOT PROVIDED. THERE WAS NO KINK NOTED ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED CONDITION; THE COIL WAS PURPOSELY DETACHED. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THE REPORTED ISSUE HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616836 GALAXY G3 4MM X 12CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLY120412 K10710 10886704077480

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown