BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 3MM X 8CM

    MDR report key: 8410393 · Received March 11, 2019

    Report

    Report Number
    3008114965-2019-00942
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    December 5, 2018
    Report Date
    December 5, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077466
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). BASED ON THE PRODUCT INVESTIGATION PERFORMED ON 07-MAR-2019, THE EVENT NOW MEETS THE REQUIRED CRITERIA FOR MDR REPORTING. INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). (B)(6). (B)(4) WAS SELECTED SINCE THE IFU STATES THAT THE MICROCOIL DELIVERY SYSTEM IS INTENDED FOR ENDOVASCULAR EMBOLIZATION OF INTRACRANIAL ANEURYSMS AND THE DEVICE WAS USED IN THE INTERNAL ILIAC ARTERY. [COMPLAINT CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RIGHT INTERNAL ILIAC ARTERY ANEURYSM, THE 3MM X 8CM GALAXY G3 (GLY120308/L11705) WAS SELECTED AS THE FIRST COIL AND WAS INSERTED INTO THE 0.021¿ HEAL-EX DOUBLE MARKER (TECHNOCRAT CORPORATION) MICROCATHETER, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER DURING DELIVERY. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT AND EIGHT COILS WERE PLACED IN THE ANEURYSM. IT WAS NOT REPORTED HOW LONG THE PROCEDURE WAS DELAYED DUE TO THE EVENT, BUT THE SURGICAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE DEVICE WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THERE WAS NO EVIDENCE OF UNINTENDED DETACHMENT IN THE MICROCATHETER. NO FURTHER INFORMATION WAS OBTAINED. A NON-STERILE 3MM X 8CM GALAXY G3 WAS RETURNED FOR EVALUATION. UPON RECEIPT OF THE COMPLAINT DEVICE, VISUAL INSPECTION WAS CONDUCTED. THE HUB CONNECTOR WAS UNDAMAGED. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS FOUND KINKED AT 74 CM FROM THE PROXIMAL END OF THE DEVICE. THE RESHEATHING TOOL WAS FOUND BROKEN. THE INTRODUCER SHEATH WAS SEEN KINKED. THE EMBOLIC COIL WAS RETURNED ADVANCED OUT OF THE INTRODUCER. THE DEVICE WAS THEN EXAMINED UNDER A MICROSCOPE. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE ARTICULATING JOINT WAS SEEN INTACT IN THE INTRODUCER AND CONNECTED TO THE EMBOLIC COIL. THE DISTAL OUTER SHEATH WAS SEEN INTACT INDICATING THAT THE RESISTANCE HEATING (RH) COIL HAD NOT HEATED, AND THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE EMBOLIC COIL WAS SEEN STRETCHED, KINKED, AND TANGLED AROUND THE COILED DPU. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DEVICE WAS UNABLE TO BE ADVANCED OR RETRACTED BECAUSE OF THE EMBOLIC COIL¿S STRETCHED, KINKED, AND TANGLED CONDITION. BECAUSE OF THIS, THE DEVICE¿S ABILITY TO ADVANCE IN A MICROCATHETER IS UNABLE TO BE TESTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 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 CUSTOMER REPORT OF RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH THE MICROCATHETER COULD NOT BE EVALUATED. THE DEVICE WAS UNABLE TO BE ADVANCED IN A MICROCATHETER DUE TO ITS STRETCHED, KINKED, AND TANGLED CONDITION. THE SOURCE OF THE RESISTANCE FELT IN THE MICROCATHETER IS UNKNOWN. THE CONCOMITANT MICROCATHETER WAS NOT RETURNED AND THEREFORE, CANNOT BE TESTED. 100% OF EMBOLIC COILS ARE INSPECTED DURING MANUFACTURING. IN ADDITION, 100% OF RESHEATHING TOOLS ARE INSPECTED. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE. RESISTANCE/FRICTION DURING ADVANCEMENT IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. THE IFU STATES THE FOLLOWING: ¿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. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES.¿ OF NOTE, THE IFU ALSO STATES THAT THE MICROCOIL DELIVERY SYSTEM IS INTENDED FOR ENDOVASCULAR EMBOLIZATION OF INTRACRANIAL ANEURYSMS AND THE DEVICE WAS USED IN THE INTERNAL ILIAC ARTERY. WITHOUT THE RETURN OF THE CONCOMITANT MICROCATHETER, THE CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED. NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES NOTED TO THE RETURNED SYSTEM. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RIGHT INTERNAL ILIAC ARTERY ANEURYSM, THE 3MM X 8CM GALAXY G3 (GLY120308/L11705) WAS SELECTED AS THE FIRST COIL AND WAS INSERTED INTO THE 0.021¿ HEAL-EX DOUBLE MARKER (TECHNOCRAT CORPORATION) MICROCATHETER, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER DURING DELIVERY. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT AND EIGHT COILS WERE PLACED IN THE ANEURYSM. IT WAS NOT REPORTED HOW LONG THE PROCEDURE WAS DELAYED DUE TO THE EVENT, BUT THE SURGICAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE DEVICE WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THERE WAS NO EVIDENCE OF UNINTENDED DETACHMENT IN THE MICROCATHETER. EVALUATION OF THE RETURNED DEVICE REVEALED STRETCHING AND KINKING OF THE EMBOLIC COIL. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202912 GALAXY G3 3MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 L11705 10886704077466

    Patients

    Seq Age Sex Outcome Treatment
    1