BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 10727970 · Received October 23, 2020

    Report

    Report Number
    3008114965-2020-00446
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 5, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080312
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE INITIAL REPORTER NAME IS NOT AVAILABLE. INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING A DURAL ARTERIOVENOUS FISTULA (DAVF), THE CERENOVUS COILS WERE USED. THE 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / K10664) WAS THE FOURTH COIL CHOSEN BUT IT COULD NOT BE DETACHED USING THE ENPOWER DETACHMENT CONTROL BOX (CATALOG AND LOT# NOT PROVIDED). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. IT WAS REPORTED THAT ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT ANY APPLICATION OF FORCE. IT WAS REMOVED WITH THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI COIL FROM LOT L13706 WAS SELECTED, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER. THE PHYSICIAN TRIED TO PUSH BUT THE ISSUE CONTINUES. IT WAS REPLACED WITH A COMPETITOR COIL. THE MICROCATHETER WAS USED AGAIN WITH ANOTHER COMPETITOR COIL; IT WAS USED TO COMPLETE THE PROCEDURE. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10664) 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. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. FAILURE TO DETACH IS A KNOWN POTENTIAL PRODUCT ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THESE SITUATIONS, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING SHOULD THEY BE ENCOUNTERED DURING USE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE / VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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. 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. 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 DURING THE PROCEDURE TARGETING A DURAL ARTERIOVENOUS FISTULA (DAVF), THE CERENOVUS COILS WERE USED. THE 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / K10664) WAS THE FOURTH COIL CHOSEN BUT IT COULD NOT BE DETACHED USING THE ENPOWER DETACHMENT CONTROL BOX (CATALOG AND LOT# NOT PROVIDED). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. IT WAS REPORTED THAT ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT ANY APPLICATION OF FORCE. IT WAS REMOVED WITH THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI COIL FROM LOT L13706 WAS SELECTED, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER. THE PHYSICIAN TRIED TO PUSH BUT THE ISSUE CONTINUES. IT WAS REPLACED WITH A COMPETITOR COIL. THE MICROCATHETER WAS USED AGAIN WITH ANOTHER COMPETITOR COIL; IT WAS USED TO COMPLETE THE PROCEDURE. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190545 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 K10664 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1