BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 2CM

    MDR report key: 10953429 · Received December 5, 2020

    Report

    Report Number
    3008114965-2020-00568
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 4, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080237
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED ANEURYSM, A SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND A 7FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC) WAS INSERTED AND DELIVERED TO THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS INSERTED INTO THE ANEURYSM AND THE COIL EMBOLIZATION STARTED. CERENOVUS AND OTHER COMPETITOR COILS WERE USED AND THE 1.00MM X 2.00CM GALAXY G3 MINI COIL (GLM910020 / K10311) WAS INSERTED INTO THE MICROCATHETER. HOWEVER, THE COMPLAINT COIL COULD NOT BE INSERTED. THE SHEATH INTRODUCER WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER, BUT THE COMPLAINT COIL COULD NOT BE INSERTED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 1.00MM X 2.00CM GALAXY G3 MINI COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. NO DAMAGE WAS OBSERVED ON THE INITIAL VISUAL INSPECTION. THE INTRODUCER WAS OBSERVED SATURATED WITH RESIDUES OF DRIED BLOOD INSIDE. THE MARKER BAND WAS FOUND AT 37CM FROM THE DISTAL END. THIS IS WITHIN SPECIFICATION. A MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS INSIDE THE INTRODUCER IN KINKED CONDITION. NO OTHER DAMAGE WAS NOTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10311) 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 COMPLAINT DOCUMENTED THAT DURING THE PROCEDURE, THE 1.00MM X 2.00CM GALAXY G3 MINI COIL ENCOUNTERED RESISTANCE DURING INSERTION INTO THE CONCOMITANT MICROCATHETER AND AS A RESULT, IT COULD NOT BE INSERTED. THE RETURNED COIL WAS OBSERVED STUCK IN THE INTRODUCER IN KINKED CONDITION. THE INTRODUCER WAS ALSO OBSERVED SATURATED WITH RESIDUES OF DRIED BLOOD. THE RESIDUES OF DRIED BLOOD SUGGEST THAT ADEQUATE AND CONTINUOUS FLUSH MAY NOT HAVE BEEN MAINTAINED IN THE CONCOMITANT MICROCATHETER DURING THE ATTEMPT TO INSERT THE COMPLAINT COIL. THE KINKED CONDITION SUGGEST THAT FORCE MAY HAVE BEEN APPLIED ON THE DEVICE DURING THE ATTEMPT TO INSERT THE COMPLAINT COIL INTO THE MICROCATHETER. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK FROM OCCURRING. THE KINKED CONDITION OBSERVED ON THE EMBOLIC COIL OF THE RETURNED DEVICE WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED KINKED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE OCCURRED WHEN THE ISSUE WAS REPORTED WHEN THE COIL COULD NOT BE INSERTED INTO THE CONCOMITANT MICROCATHETER. INADVERTENT FORCE MAY HAVE BEEN EXERTED ON THE DEVICE WHICH RESULTED IN THE KINKED EMBOLIC COIL. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 1.00MM X 2.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN THE OBSERVED KINKED CONDITION. 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. 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 · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED ANEURYSM, A SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND A 7FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC) WAS INSERTED AND DELIVERED TO THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS INSERTED INTO THE ANEURYSM AND THE COIL EMBOLIZATION STARTED. CERENOVUS AND OTHER COMPETITOR COILS WERE USED AND THE 1.00MM X 2.00CM GALAXY G3 MINI COIL (GLM910020 / K10311) WAS INSERTED INTO THE MICROCATHETER. HOWEVER, THE COMPLAINT COIL COULD NOT BE INSERTED. THE SHEATH INTRODUCER WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER, BUT THE COMPLAINT COIL COULD NOT BE INSERTED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE 1.00MM X 2.00CM GALAXY G3 MINI COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420311 GALAXY G3 MINI 1MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910020 K10311 10886704080237

    Patients

    Seq Age Sex Outcome Treatment
    1