BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 10174555 · Received June 19, 2020

    Report

    Report Number
    3008114965-2020-00251
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 5, 2020
    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

    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 NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. INITIAL REPORTER ADDRESS: (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10166) FAILED TO BE RE-ZIPPED / RE-SHEATHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR 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 DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 1.00MM X 4.00CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED WITHOUT ANY DAMAGE NOTED. THE DEVICE UNDERWENT A MICROSCOPIC INSPECTION. THE MARKER BAND WAS FOUND AT 39CM FROM THE DISTAL END; THIS IS WITHIN SPECIFICATION. THE EMBOLIC COIL WAS INSIDER THE INTRODUCER AND IN STRETCHED CONDITION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10166) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCE'S RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT DOCUMENTED THAT THE 1.00MM X 4.00CM GALAXY G3 MINI COIL FAILED TO BE RE-ZIPPED / RE-SHEATHED. THE REPORTED ISSUE WAS NOT CONFIRMED. THERE WAS NO DAMAGE NOTED ON THE COIL INTRODUCER; THE INTRODUCER WAS ZIPPED AND UNZIPPED WITHOUT ANY ISSUE. THE COMPLAINT HAS LIMITED INFORMATION RELATED TO THE PROCEDURE AND THE DEVICE ISSUE ENCOUNTERED DURING THE PROCEDURE. THE OBSERVED STRETCHED CONDITION OF THE EMBOLIC COIL OF THE RETURNED DEVICE WAS LIKELY CAUSED BY APPLIED FORCE. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. STRETCHING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THE STRETCHED CONDITION OF THE EMBOLIC COIL WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED STRETCHED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF INADVERTENT FORCE THAT MAY HAVE BEEN APPLIED DURING THE ATTEMPT TO RESHEATH THE COIL. 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 1.00MM X 4.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN A STRETCHED CONDITION. 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 OF FAILURE TO DETACH WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 THE 1.00MM X 4.00CM GALAXY G3 MINI COIL (GLM910040 / K10166) FAILED TO BE RE-ZIPPED / RE-SHEATHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR 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 DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION INSIDE THE INTRODUCER. BASED ON THE PRODUCT ANALYSIS 6/18/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640822 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 K10166 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1