BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 10022731 · Received May 4, 2020

    Report

    Report Number
    3008114965-2020-00114
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 6, 2020
    Report Date
    April 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(6). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE LAB ON (B)(6) 2020; THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A CEREBRAL ANEURYSM, THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE TARGET LESION AND AFTER TWO COMPETITOR COILS WERE DELIVERED, THE COMPLAINT COIL, A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / L16329) WAS CHOSEN. THE COMPLAINT COIL GOT STUCK ON THE SHEATH AND COULD NOT BE INSERTED INTO THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J JAPAN AFFILIATES AND INCLUDED IN THE COMPLAINT FILE. THE PHOTOS UNDERWENT REVIEW BY THE PRODUCT ANALYSIS LAB. BASED ON THE PHOTOS, THE COIL WAS PARTIALLY PROTRUDING FROM THE INTRODUCER SHEATH AND APPEARED TO BE FOLDED IN AN AREA DISTAL FROM THE RESISTANCE HEATING (RH) COIL. RESIDUES OF DRIED BLOOD WERE NOTED ON THE INTRODUCER. THE DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2.00MM X 6.00CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE COIL INTRODUCER WAS OBSERVED SATURATED WITH RESIDUES OF DRIED BLOOD AND SALINE SOLUTION INSIDE THE LUMEN. A MICROSCOPIC INSPECTION WAS PERFORMED. THE MARKER BAND WAS FOUND AT 41 CM FROM THE DISTAL END; THIS IS WITHIN SPECIFICATION. THE EMBOLIC COIL WAS OBSERVED KINKED AND IN A FOLDED CONFIGURATION INSIDE THE INTRODUCER; IT WAS ALSO NOTED TO BE PROTRUDING FROM THE INTRODUCER. NO OTHER DAMAGE WAS OBSERVED. THE MICROSCOPIC OBSERVATIONS NOTED ON THE RETURNED DEVICE ARE CONSISTENT WITH WHAT WAS DOCUMENTED ON THE PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE. THE EMBOLIC COIL WAS NOTED TO BE PARTIALLY PROTRUDING FROM THE INTRODUCER SHEATH, IT WAS IN A FOLDED CONFIGURATION AND RESIDUES OF THE DRIED BLOOD AND SALINE SOLUTION WAS OBSERVED INSIDE THE INTRODUCER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L16329) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT DOCUMENTED THAT THE COMPLAINT COIL BECAME STUCK ON THE SHEATH AND COULD NOT BE INSERTED IN THE CONCOMITANT MICROCATHETER WAS CONFIRMED BASED ON THE OBSERVATIONS MADE DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE. THE KINKED AND FOLDED CONFIGURATION OF THE EMBOLIC COIL MAY ALSO HAVE BEEN CONTRIBUTING FACTORS TO THE REPORTED ISSUE. THE KINKED CONDITION OBSERVED ON THE RETURNED EMBOLIC COIL AND THE FOLDED CONFIGURATION OF THE COIL WERE NOT ORIGINALLY REPORTED WITH THE COMPLAINT. 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 EXACT CAUSE OF THE OBSERVED KINKED 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 INSERT THE COMPLAINT DEVICE INTO THE CONCOMITANT MICROCATHETER. FORCE THAT IS ENOUGH TO CAUSE THE EMBOLIC COIL TO BECOME KINKED AND POSSIBLY BECOME FOLDED AS OBSERVED ON THE RETURNED DEVICE DURING THE MICROSCOPIC INSPECTION. THE RESIDUES OF DRIED BLOOD AND SALINE SOLUTION OBSERVED IN THE LUMEN OF THE INTRODUCER ALSO SUGGEST THAT CONTINUOUSLY AND ADEQUATE FLUSH MAY HAVE ALSO CONTRIBUTED TO THE REPORTED ISSUE IN THE COMPLAINT. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, 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 2.00MM X 6.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL KINKED AND IN A FOLDED CONFIGURATION 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. 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, WEIGHT, RACE, AND ETHNICITY, WERE NOT PROVIDED. 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 PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE REPORTED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (FREMONT). 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. [PHOTO ANALYSIS]: THE PHOTOS OF THE COMPLAINT DEVICE WERE INCLUDED IN THE COMPLAINT FILE. BASED ON THE PHOTOS, THE COIL WAS PARTIALLY PROTRUDING FROM THE INTRODUCER SHEATH AND APPEARED TO BE FOLDED IN AN AREA DISTAL FROM THE RESISTANCE HEATING (RH) COIL. RESIDUES OF DRIED BLOOD WERE NOTED ON THE INTRODUCER. FURTHER INVESTIGATION WILL BE PERFORMED ONCE THE COMPLAINT DEVICE IS RECEIVED FOR EVALUATION AND ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L16329) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. 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 COIL EMBOLIZATION PROCEDURE TARGETING A CEREBRAL ANEURYSM, THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE TARGET LESION AND AFTER TWO COMPETITOR COILS WERE DELIVERED, THE COMPLAINT COIL, A 2.00MM X 6.00CM (B)(4) (GLM920060 / L16329) WAS CHOSEN. THE COMPLAINT COIL GOT STUCK ON THE SHEATH AND COULD NOT BE INSERTED INTO THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J (B)(6) AFFILIATES. BASED ON THE REVIEW OF THE PHOTOS BY THE PRODUCT ANALYSIS LAB ON 4/20/2020, THE COIL WAS PARTIALLY PROTRUDING FROM THE INTRODUCER SHEATH AND APPEARED TO BE FOLDED IN AN AREA DISTAL FROM THE RESISTANCE HEATING (RH) COIL. THERE WERE RESIDUES OF DRIED BLOOD ON THE INTRODUCER. THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484391 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 L16329 10886704080312

    Patients

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