BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 14470303 · Received May 23, 2022

    Report

    Report Number
    3008114965-2022-00359
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 29, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 4CM GALAXY G3 COIL (GLM920040, K10750) WAS BEING USED AS THE SECOND COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED TO CERENOVUS FOR FURTHER EVALUATION. A NON-STERILE GALAXY G3 MINI 2MM X 4CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON ARRIVAL, THE DEVICE WAS VISUALLY INSPECTED, AND THE INTRODUCER WAS RETURNED SEPARATED FROM THE UNIT, BUT NO DAMAGES WERE FOUND ON IT. NO OTHER DAMAGES WERE FOUND IN THE DEVICE. UNDER MICROSCOPIC MAGNIFICATION, THE EMBOLIC COIL WAS FOUND TO BE STRETCHED AND WITH MULTIPLE KINKS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. COIL STRETCHING AND COIL KINKING ARE KNOWN POTENTIAL ISSUES 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. STRETCHING AND KINKING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THE COMPLAINT DOCUMENTED THAT THE COIL COULD NOT BE ADVANCED THROUGH NOR RETRIEVED FROM THE CONCOMITANT MICROCATHETER; THE COMPLAINT COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. IT IS POSSIBLE THAT FORCE MAY HAVE INADVERTENTLY BEEN APPLIED DURING THE COIL ADVANCEMENT IN ATTEMPT TO OVERCOME THE RESISTANCE WHICH RESULTED IN THE COIL KINKING. SIMILARLY, FORCE MAY HAVE INADVERTENTLY BEEN APPLIED DURING THE COIL REMOVAL FROM THE MICROCATHETER WHICH RESULTED IN THE COIL STRETCHING. ALTHOUGH THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RECEIVED, THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE APPEARANCE OF THE EMBOLIC COIL. WITH THE LIMITED INFORMATION AVAILABLE, AN ASSIGNMENT OF A ROOT CAUSE IS NOT POSSIBLE. HOWEVER, IT IS SUSPECTED THAT THE DAMAGES DESCRIBED ABOVE ARE THE RESULT OF THE MANIPULATION REQUIRED TO ADVANCE AND WITHDRAW THE EMBOLIC COIL FROM THE MICROCATHETER. FACTORS NOT DESCRIBED IN THE EVENT DESCRIPTION, SUCH AS INADEQUATE FLUSH, MAY HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCE WAS FOUND DURING THE REVIEW. 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 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. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 4CM GALAXY G3 COIL (GLM920040, K10750) WAS BEING USED AS THE SECOND COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551629 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920040 K10750 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED MICROCATHETER