BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 12274978 · Received August 4, 2021

    Report

    Report Number
    3008114965-2021-00373
    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
    10886704080251
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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)(6). MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 AND 3008114965-2021-00374. 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 1MM X 4CM WAS RECEIVED AT CERENOVUS FOR ANALYSIS. THE DEVICE WAS INSPECTED, AND IT WAS FOUND THAT THE CORE WIRE IS KINKED AND PROTRUDING FROM INTRODUCER, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. THE EMBOLIC COIL WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND INSIDE THE INTRODUCER WITH A DAMAGE CONDITION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE PROTRUDED CONDITION NOTED ON THE DEVICE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10748 NUMBER, AND NO NON-CONFORMANCE'S 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 THE CORE WIRE IS KINKED AND PROTRUDED FROM INTRODUCER, THESE CONDITIONS ARE RELATED WITH THE CUSTOMER COMPLAINT REGARDING ¿COIL INTRODUCER - PRESCORE RUPTURE¿. BASED ON THE FINDINGS DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MICROSCOPIC TEST WAS PERFORMED, AND IT WAS FOUND THAT THE EMBOLIC COIL IS INSIDE THE INTRODUCER WITH A DAMAGE CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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. DO NOT FASTEN THE RHV VALVE TOO TIGHTLY AROUND THE INTRODUCER SHEATH SINCE EXCESSIVE PRESSURE MAY CAUSE DAMAGE TO THE INTRODUCER SHEATH AND/OR THE MICROCOIL AS IT IS ADVANCED INTO THE INFUSION MICROCATHETER. ADDITIONALLY, IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED, DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION. 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
    1174139 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 K10748 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 GALAXY G3 MINI 2MM X 6CM| SL10 MICROCATHETER (STRYKER)