BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 3CM

    MDR report key: 10421253 · Received August 18, 2020

    Report

    Report Number
    3008114965-2020-00317
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080299
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT ON 09/22/2020; THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE 2.00MM X 3.00CM GALAXY G3 MINI COIL (GLM920030 / K10227) WAS THE FIFTH COIL USED, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE ISSUE WAS ENCOUNTERED WHEN THE COIL WAS AT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND CONFIRMED THAT THE COIL HAD ALREADY DETACHED; IT WAS CONFIRMED THAT THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AS THE DETACHED COIL WAS INSIDE THE CONCOMITANT MICROCATHETER. THERE WERE NO VISUAL ABNORMALITIES ON THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE DELIVERY WIRE WAS PROTRUDING FROM THE INTRODUCER SHEATH. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER, A HEADWAY® DUO (MICROVENTION-TERUMO) AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZE MINI COIL. THE PROCEDURE WAS COMPLETED WITH FIVE IMPLANTED COILS. THE REPORTED ISSUE RELATED TO THE COIL DID NOT RESULT IN ANY BLOOD FLOW REDUCTION OR REDUCTION; THERE WAS NO REPORT OF ANY CLINICALLY SIGNIFICANT PROCEDURAL DELAY AND THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. INVESTIGATION SUMMARY: THE PRODUCT ANALYSIS RECEIVED ONLY THE CONCOMITANT SL-10® MICROCATHETER THAT WAS CUT IN 14 PARTS. THE COMPLAINT COIL, THE 2.00MM X 3.00CM GALAXY G3 MINI COIL WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT DOCUMENTED THAT THE PHYSICIAN RETRACTED THE COIL AND CONFIRMED IT HAD DETACHED INSIDE THE MICROCATHETER. A GUIDEWIRE WAS EMPLOYED TO INSERT INTO EACH OF THE 14 CUT PORTIONS OF THE MICROCATHETER IN ORDER TO FIND OUT AND VERIFY THE PRESENCE OF THE EMBOLIC COIL. THE EMBOLIC COIL WAS NOT IN ANY OF THE 14 PARTS OF THE MICROCATHETER. 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. IF THE 2.00MM X 3.00CM GALAXY G3 MINI COIL IS RETURNED, PRODUCT INVESTIGATION WILL BE PERFORMED, AND THE FILE WILL BE UPDATED ACCORDINGLY. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10227) 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 REPORTED ISSUE IN THE COMPLAINT THAT THE FIFTH COIL CHOSEN FOR THE PROCEDURE WAS THE 2.00MM X 3.00CM GALAXY G3 MINI COIL, BUT THE COIL ENCOUNTERED RESISTANCE WITH THE CONCOMITANT MICROCATHETER AT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. DURING COIL RETRACTION FOR REMOVAL, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE REPORTED ISSUES COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED BUT WITHOUT THE COMPLAINT COIL AVAILABLE FOR ANALYSIS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE; 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 WITH THE RESISTANCE ENCOUNTERED AT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER WHICH RESULTED IN THE PREMATURE DETACHMENT OF THE EMBOLIC COIL IN THE MICROCATHETER DURING COIL RETRACTION FOR REMOVAL. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 8/31/2020. [ADDITION EVENT INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE 2.00MM X 3.00CM GALAXY G3 MINI COIL (GLM920030 / K10227) WAS THE FIFTH COIL USED, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE ISSUE WAS ENCOUNTERED WHEN THE COIL WAS AT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND CONFIRMED THAT THE COIL HAD ALREADY DETACHED; IT WAS CONFIRMED THAT THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AS THE DETACHED COIL WAS INSIDE THE CONCOMITANT MICROCATHETER. THERE WERE NO VISUAL ABNORMALITIES ON THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE DELIVERY WIRE WAS PROTRUDING FROM THE INTRODUCER SHEATH. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER, A HEADWAY® DUO (MICROVENTION-TERUMO) AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZE MINI COIL. THE PROCEDURE WAS COMPLETED WITH FIVE IMPLANTED COILS. THE REPORTED ISSUE RELATED TO THE COIL DID NOT RESULT IN ANY BLOOD FLOW REDUCTION OR REDUCTION; THERE WAS NO REPORT OF ANY CLINICALLY SIGNIFICAN PROCEDURAL DELAY AND THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. 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).. PROCODE IS KRD/HCG. 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 (K10227) 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 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 COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE 2.00MM X 3.00CM GALAXY G3 MINI COIL (GLM920030 / K10227) WAS THE FIFTH COIL USED, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE ISSUE WAS ENCOUNTERED WHEN THE COIL WAS AT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND CONFIRMED THAT THE COIL HAD ALREADY DETACHED; IT WAS CONFIRMED THAT THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AS THE DETACHED COIL WAS INSIDE THE CONCOMITANT MICROCATHETER. THERE WERE NO VISUAL ABNORMALITIES ON THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE DELIVERY WIRE WAS PROTRUDING FROM THE INTRODUCER SHEATH. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER, A HEADWAY® DUO (MICROVENTION-TERUMO) AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZE MINI COIL. THE PROCEDURE WAS COMPLETED WITH FIVE IMPLANTED COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886502 GALAXY G3 MINI 2MM X 3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920030 K10227 10886704080299

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-10® MICROCATHETER (STRYKER)