BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1.5MM X 3CM

    MDR report key: 10404898 · Received August 13, 2020

    Report

    Report Number
    3008114965-2020-00313
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080145
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE RETURNED COMPLAINT DEVICE ON 09/01/2020; THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE SAME PROCEDURE, THE 1.50MM X 3.00CM GALAXY G3 MINI COIL (GLM915030 / K10226) WAS ONE OF TWO COILS THAT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. AS A RESULT, THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER FROM THE PATIENT AT THE SAME TIME. AFTER INSPECTION, THE EMBOLIC COIL WAS NOTED TO BE IN A STRETCHED CONDITION. ANOTHER 1.50MM X 3.00CM GALAXY G3 MINI COIL WAS USED AS THE REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE PRODUCT WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 1.50MM X 3.00CM GALAXY G3 MINI COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT (DPU) WAS KINKED AT 26/7CM FROM THE PROXIMAL END. THE DPU WAS ALSO PROTRUDING FROM THE INTRODUCER. THE MARKER BAND WAS FOUND AT 37.9CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. NO OTHER DAMAGES NOR ANOMALIES WERE OBSERVED. A MICROSCOPIC INSPECTION AS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL WAS OBSERVED IN KINKED / DAMAGED CONDITION. FUNCTIONAL EVALUATION COULD NOT BE CONDUCTED DUE TO THE CONDITION OF THE DPU BEING KINKED AND PROTRUDING FROM THE COIL INTRODUCER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10226) 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 COMPLAINT DOCUMENTED THAT DURING THE PROCEDURE, THE 1.50MM X 3.00CM GALAXY G3 MINI COIL WAS ONE OF TWO COILS THAT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE ISSUE PROMPTED FOR THE REMOVAL OF THE COIL AND THE CONCOMITANT MICROCATHETER. AFTER INSPECTION, THE COIL WAS NOTED TO BE IN STRETCHED CONDITION. THE REPORTED ISSUE RELATED TO THE COIL NOT BEING ABLE TO BE ADVANCED NOR RETRIEVED WAS NOT CONFIRMED THROUGH FUNCTIONAL EVALUATION AS THE DPU WAS KINKED AND PROTRUDING FROM THE INTRODUCER PRECLUDED THE DEVICE FROM UNDERGOING FUNCTIONAL EVALUATION. HOWEVER, THE OBSERVATION OF THE DPU BEING KINKED AND PROTRUDING FROM THE INTRODUCER CONFIRMED THE REPORTED ISSUE. THE DPU IN THIS CONDITION WOULD PREVENT THE COIL FROM BEING ADVANCED AND RETRACTED AS REPORTED IN THE COMPLAINT. THE COIL WAS REPORTED AS STRETCHED; THE MICROSCOPIC OBSERVATION NOTED THAT THE COIL WAS KINKED. THE REPORTED ISSUE WAS CONFIRMED. COIL STRETCHING / KINKING ARE KNOWN POTENTIAL ISSUES ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS STRETCHING AND KINKING FROM OCCURRING. THE COMPLAINT REPORTED THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER FROM THE PATIENT WHEN THE COIL WAS HAVING ISSUE WITH BEING ADVANCED AND RETRIEVED, THE COIL WAS EXAMINED AND FOUND TO BE STRETCHED. THE EXACT CAUSE OF THE REPORTED COIL CONDITION AND THE OBSERVED DAMAGED COIL CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS MOST LIKELY THAT DURING THE ATTEMPT TO ADVANCE / RETRIEVE THE COIL DURING THE PROCEDURE, UNDUE FORCE WAS APPLIED INADVERTENTLY CAUSING THE COIL TO KINK AS OBSERVED ON THE RETURNED DEVICE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 1.50MM X 3.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN THE CONDITION THAT WAS OBSERVED ON THE RETURNED DEVICE, WITH THE COIL KINKED. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2020-00313 AND 3008114965-2020-00315. 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.

    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 NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / 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 REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10226) 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2020-00315. 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 SAME PROCEDURE, THE 1.50MM X 3.00CM GALAXY G3 MINI COIL (GLM915030 / K10226) WAS ONE OF TWO COILS THAT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. AS A RESULT, THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER FROM THE PATIENT AT THE SAME TIME. AFTER INSPECTION, THE EMBOLIC COIL WAS NOTED TO BE IN A STRETCHED CONDITION. ANOTHER 1.50MM X 3.00CM GALAXY G3 MINI COIL WAS USED AS THE REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865998 GALAXY G3 MINI 1.5MM X 3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM915030 K10226 10886704080145

    Patients

    Seq Age Sex Outcome Treatment
    1 GALAXY G3 MINI 1MM X 3CM