BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 3CM

    MDR report key: 10080758 · Received May 21, 2020

    Report

    Report Number
    3008114965-2020-00180
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    March 31, 2020
    Report Date
    March 31, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080244
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4).. PROCODE IS KRD/HCG. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 3.00CM GALAXY G3 MINI COIL (GLM910030 / K10312) WAS CHECKED BEFORE IT WAS INSERTED IN THE PATIENT. HOWEVER, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PUSH THE COIL INTO THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) DURING THE INSERTION. THE COIL COLD NOT COMPLETELY BE MOVED INTO THE MICROCATHETER. CONTINOUS FLUSH WAS MAINTAINED IN THE MICROCATHETER. IT WAS REPORTED THAT THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END. FORCE WAS NOT APPLIED. THERE WAS NO DAMAGE OBSERVED ON THE COIL. THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION; THE SAME MICROCATHETER WAS USED FOR FURTHER COILING IN THE PROCEDURE. 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 3.00CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT (DPU) WAS OBSERVED WITH SEVERAL KINKED AREAS AND PROTRUDING FROM THE INTRODUCER. A MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED STUCK INSIDE THE INTRODUCER AND NOTED TO BE KINKED. NO OTHER DAMAGE WAS OBSERVED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10312) 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 THE 1.00MM X 3.00CM GALAXY G3 MINI COIL WAS CHECKED BEFORE IT WAS INSERTED BUT IT COULD NOT BE MOVED INTO THE MICROCATHETER. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE EMBOLIC COIL WAS STUCK INSIDE THE INTRODUCER AND WAS NOTED TO BE IN KINKED CONDITION. THE CONDITION OF THE RETURNED DEVICE AS OBSERVED DURING THE MICROSCOPIC INSPECTION CONFIRMED THE REPORTED ISSUE. THE KINKED EMBOLIC COIL AND IT BEING STUCK IN THE INTRODUCER CAN BE A FACTOR CONTRIBUTED TO THE REPORTED ISSUE. THE KINKED CONDITION OF THE COIL SUGGEST THAT FORCE MAY HAVE INADVERTENTLY BEEN APPLIED DURING THE ATTEMPT TO PUSH THE COIL INTO THE CONCOMITANT MICROCATHETER; THE FORCE MAY HAVE RESULTED IN THE EMBOLIC COIL BECOMING KINKED. THE KINKED CONDITION OBSERVED ON THE RETURNED EMBOLIC COIL WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK FROM OCCURRING. THE EXACT CAUSE OF THE OBSERVED KINKED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF INADVERTENT FORCE THAT MAY HAVE BEEN APPLIED DURING THE ATTEMPT TO INSERT THE COMPLAINT DEVICE INTO THE CONCOMITANT MICROCATHETER. FORCE THAT IS ENOUGH TO CAUSE THE EMBOLIC COIL TO BECOME KINKED AS OBSERVED ON THE RETURNED DEVICE DURING THE MICROSCOPIC INSPECTION. THE KINKED CONDITION OF THE EMBOLIC COIL WOULD HAVE BEEN NOTICED WHEN THE DEVICE WAS CHECKED AT THE START OF THE PROCEDURE. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, 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 3.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE 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 THE 1.00MM X 3.00CM GALAXY G3 MINI COIL (GLM910030 / K10312) WAS CHECKED BEFORE IT WAS INSERTED IN THE PATIENT. HOWEVER, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PUSH THE COIL INTO THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) DURING THE INSERTION. THE COIL COLD NOT COMPLETELY BE MOVED INTO THE MICROCATHETER. CONTINOUS FLUSH WAS MAINTAINED IN THE MICROCATHETER. IT WAS REPORTED THAT THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END. FORCE WAS NOT APPLIED. THERE WAS NO DAMAGE OBSERVED ON THE COIL. THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION; THE SAME MICROCATHETER WAS USED FOR FURTHER COILING IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS (B)(6) /2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541894 GALAXY G3 MINI 1MM X 3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910030 K10312 10886704080244

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR