BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 13726976 · Received March 10, 2022

    Report

    Report Number
    3008114965-2022-00187
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 10, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080251
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). PROCODE IS KRD/HCG. CONCLUSION: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL COMPONENT OF THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10217) WAS IMPEDED AND COULD NOT BE ADVANCED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 1.00MM X 4.00CM GALAXY G3 MINI COIL WAS RECEIVED. VISUAL INSPECTION WAS PERFORMED. THE COIR WIRE AND INTRODUCER WERE OBSERVED IN GOOD CONDITION. THERE WAS NO EVIDENCE OF DAMAGE NOTED. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL COMPONENT IS OBSERVED IN KINKED CONDITION INSIDE THE INTRODUCER. THE INTRODUCER WAS FLUSHED AND IT WAS CONCLUDED THAT NOTHING WAS OBSTRUCTING THE INTRODUCER. HOWEVER, DUE TO THE KINKED CONDITION OF THE EMBOLIC COIL, IT COULD NOT BE ADVANCED OUT. THIS OBSERVATION IS POSSIBLY SECONDARY TO THE REPORTED ISSUE THAT THE COIL WAS IMPEDED AND COULD NOT BE ADVANCED DURING THE PROCEDURE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10217) 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. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE FINDINGS NOTED ON THE EMBOLIC COIL. HOWEVER, NO CONTRIBUTING FACTORS COULD BE IDENTIFIED FROM THE DEVICE. THE EXACT TIMING WHEN THIS CONDITION OCCURRED COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING PRECAUTION: NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. MANIPULATION OF THE DELIVERY TUBE AGAINST RESISTANCE CAN CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE COIL. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK FROM OCCURRING. THE COIL KINKED CONDITION WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED KINKED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT WHEN THE COIL COULD NOT BE ADVANCED DURING THE PROCEDURE, SOME FORCE MAY HAVE INADVERTENTLY BEEN APPLIED DURING THE ATTEMPT TO ADVANCE THE COIL. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION RELATED TO THE PROCEDURE, TO THE REPORTED DEVICE ISSUE DID NOT YIELD ANY RESPONSE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 1.00MM X 4.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN A KINKED CONDITION AS OBSERVED ON THE RETURNED DEVICE. 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 · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL COMPONENT OF THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10217) WAS IMPEDED AND COULD NOT BE ADVANCED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10217), THE EMBOLIC COIL COMPONENT WAS OBSERVED IN A KINKED CONDITION INSIDE THE INTRODUCER. BASED ON THE PRODUCT ANALYSIS ON 10-MAR-2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117718 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 K10217 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown