BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 12274977 · Received August 4, 2021

    Report

    Report Number
    3008114965-2021-00374
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    May 14, 2021
    Report Date
    May 16, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080312
    PMA / PMN Number
    K171862
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED AS BEING DAMAGED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE:(B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2021-00373. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE RIGHT INTERNAL CAROTID-ANTERIOR CHOROIDAL (IC-ACHOA) ARTERY WHOSE LENGTH WAS 5X3.4MM. A 3.5MM X 9CM GALAXY G3 COIL (UNKNOWN PRODUCT/LOT NUMBER WAS USED BUT THE SIZE DID NOT FIT THE LESION. IT WAS RE-SHEATHED. A 4MM X 10CM GALAXY G3 COIL (UNKNOWN PRODUCT/LOT NUMBER) WAS USED AS A FRAMING COIL. THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 COIL (GLM920060, 30504541) WAS USED, HOWEVER, THE COIL PROTRUDED FROM THE SHEATH SIDE. IT WAS REMOVED FROM THE PATIENT. TWO UNSPECIFIED SAME SIZED COILS WERE USED. THE OTHER COMPLAINT COIL, A 1MM X 4CM GALAXY G3 COIL (GLM910040, K10748) WAS USED AS THE FINISHING COIL BUT THE COIL PART DID NOT COME OUT FROM THE SHEATH. IT WAS REMOVED FROM THE PATIENT. TWO UNSPECIFIED SAME SIZED COILS WERE USED. THE PROCEDURE WAS COMPLETED AFTER A 1MM X 3CM GALAXY G3 COIL (1X3) WAS USED AS A FINISHING COIL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE GALAXY G3 MINI 2MM X 6CM WAS RECEIVED AT CERENOVUS FOR ANALYSIS. THE DEVICE WAS INSPECTED, AND IT WAS FOUND IN GOOD NORMAL CONDITIONS, NO DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND THAT THE EMBOLIC COIL IS STUCK INSIDE THE INTRODUCER WITH A DAMAGE CONDITION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE EMBOLIC COIL BEING STUCK INSIDE THE INTRODUCER WITH A DAMAGE CONDITION. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 30504541 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CERENOVUS CONDUCTED A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RETURNED. THE VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT NO DAMAGES WERE OBSERVED. A MICROSCOPIC TEST WAS PERFORMED, AND IT WAS FOUND THAT THE EMBOLIC COIL IS STUCK INSIDE THE INTRODUCER WITH A DAMAGE CONDITION, THE STUCK AND DAMAGE CONDITIONS ARE RELATED TO THE CUSTOMER COMPLAINT REGARDING ¿COIL - IMPEDED-IN INTRODUCER¿. BASED ON THE FINDINGS DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IMPEDED IN INTRODUCER IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: 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. AFTER FLUSHING, REINSERT THE INTRODUCER INTO THE INFUSION CATHETER HUB AS DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. 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 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. IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE MICROCATHETER AT OR SLIGHTLY INSIDE THE OSTIUM (NECK) OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER. PULLING THE EXPOSED MICROCOIL THROUGH THE RHV GROMMET MAY DAMAGE THE COIL. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES ON THE RETURNED SYSTEM. THE EVENT DESCRIPTION DOES NOT REPORT ANY DAMAGE OF THE EMBOLIC COIL. HOWEVER, 100% OF DEVICES ARE INSPECTED FOR DAMAGE AT THE QUALITY CONTROL (QC) FINAL INSPECTION. THUS, IT IS VERY UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE. 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 · 1

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE RIGHT INTERNAL CAROTID-ANTERIOR CHOROIDAL (IC-ACHOA) ARTERY WHOSE LENGTH WAS 5X3.4MM. A 3.5MM X 9CM GALAXY G3 COIL (UNKNOWN PRODUCT/LOT NUMBER WAS USED BUT THE SIZE DID NOT FIT THE LESION. IT WAS RE-SHEATHED. A 4MM X 10CM GALAXY G3 COIL (UNKNOWN PRODUCT/LOT NUMBER) WAS USED AS A FRAMING COIL. THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 COIL (GLM920060, 30504541) WAS USED, HOWEVER, THE COIL PROTRUDED FROM THE SHEATH SIDE. IT WAS REMOVED FROM THE PATIENT. TWO UNSPECIFIED SAME SIZED COILS WERE USED. THE OTHER COMPLAINT COIL, A 1MM X 4CM GALAXY G3 COIL (GLM910040, K10748) WAS USED AS THE FINISHING COIL BUT THE COIL PART DID NOT COME OUT FROM THE SHEATH. IT WAS REMOVED FROM THE PATIENT. TWO UNSPECIFIED SAME SIZED COILS WERE USED. THE PROCEDURE WAS COMPLETED AFTER A 1MM X 3CM GALAXY G3 COIL (1X3) WAS USED AS A FINISHING COIL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE 2MM X 6CM GALAXY G3 COIL AND THE 1MM X 4CM GALAXY G3 COIL RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174137 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 30504541 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1 GALAXY G3 MINI 1MM X 4CM.| SL10 MICROCATHETER (STRYKER).