BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 8MM X 24CM

    MDR report key: 8149162 · Received December 10, 2018

    Report

    Report Number
    3008114965-2018-00830
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077589
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / KNOWN. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE VENOUS FISTULA COILING PROCEDURE ON NORMAL VENOUS ANATOMY TARGETING THE TRANSVERSE SINUS, THE 8MM X 24CM GALAXY G3 COIL (GLY120824 / L10800) WAS REPORTED TO HAVE ISSUE ADVANCING FROM THE COIL INTRODUCER. THE COIL WAS FLUSHED AGAIN, BUT IT STILL DID NOT ADVANCE FROM THE COIL INTRODUCER. IT WAS REPORTED THAT THE END USER TRIED TO UNLOCK THE COIL FROM THE LOCKING TOOL, BUT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER. THE COIL DID NOT ENTER THE MICROCATHETER (EXCELSIOR¿ SL-10¿, STRYKER). IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED ON THE GALAXY G3 COIL; NO BEND OR KINKS WERE NOTED ON THE MICROCATHETER. THE GALAXY G3 COIL WAS REMOVED FROM THE PATIENT BUT THE MICROCATHETER WAS LEFT IN THE PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT CONSEQUENCE; THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE 8MM X 24CM GALAXY G3 COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE 8MM X 24CM GALAXY G3 COIL WAS RETURNED WITH ITS ORIGINAL PACKAGING. THE PACKAGING LABEL MATCHED THE INFORMATION DOCUMENTED IN THE COMPLAINT. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL ADVANCED FROM THE INTRODUCER. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS SEEN PROTRUDING FROM THE INTRODUCER SKIVE. IT ENTERED THE DISTAL END OF THE RESHEATHING TOOL OUTSIDE THE INTRODUCER. A KINK WAS OBSERVED ON THE DPU CORE WIRE APPROXIMATELY 109 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE EMBOLIC COIL WAS SEEN KINKED IN TWO LOCATIONS ALONG ITS LENGTH. THE ARTICULATING JOINT WAS SEEN INTACT. THE DISTAL OUTER SHEATH HAD NOT SOFTENED INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN NOT DAMAGED. THE DEVICE COULD NOT BE ADVANCED THROUGH A LAB MICROCATHETER. THE LENGTH OF THE EMBOLIC COIL WAS GREATER THAN THE LENGTH FROM THE DISTAL END OF THE GREEN INTRODUCER TO THE POINT WHERE THE DPU CORE WIRE PROTRUDES FROM THE INTRODUCER SKIVE. THEREFORE, THE COIL CANNOT BE RETRACTED COMPLETELY INTO THE SHEATH TO BE IN A POSITION ABLE TO BE ADVANCED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L10800) 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. INVESTIGATION CONCLUSION: THE REPORTED ISSUE THAT THE COIL WAS IMPEDED IN THE INTRODUCER WAS NOT CONFIRMED DURING THE PRODUCT EVALUATION. THE EMBOLIC COIL COULD NOT BE ADVANCED FROM THE INTRODUCER SHEATH DUE TO THE CONDITION IN WHICH IT WAS RETURNED. THE EMBOLIC COIL WAS NOT ABLE TO BE ADVANCED FROM THE COIL INTRODUCER BECAUSE IT COULD NOT BE RETRACTED BACK INTO THE SHEATH WITHOUT PROTRUDING FROM THE INTRODUCER SKIVE. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT DESCRIPTION TO DETERMINE THE CAUSE OF THE REPORTED FAILURE. THE COMPLAINT DESCRIPTION DID NOT DOCUMENT WHETHER THE FLUSH WAS MAINTAINED PRIOR TO THE FIRST INSTANCE OF ADVANCEMENT ISSUE DURING THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) PROVIDES INSTRUCTIONS FOR WHEN RESISTANCE IS FELT DURING DEVICE ADVANCEMENT THROUGH THE DELIVERY SYSTEM. DEVICES UNDERGO 100% TEST INSPECTION FOR MOVEMENT THROUGH THE SHEATH. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR DAMAGE TO THE EMBOLIC COIL. THE KINKS OBSERVED AT THE TWO LOCATIONS ALONG THE LENGTH OF THE EMBOLIC COIL WOULD HAVE BEEN CAUGHT DURING FINAL INSPECTION; IT IS VERY UNLIKELY THAT THE 8MM X 24CM GALAXY G3 COIL LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED KINKS ALONG ITS LENGTH. THE REPORTED ISSUE THAT THE COIL WAS IMPEDED IN THE INTRODUCER WAS NOT CONFIRMED THROUGH EVALUATION AND ANALYSIS OF THE RETURNED DEVICE. THE COIL WAS NOTED TO BE KINKED IN TWO LOCATIONS. THE INFORMATION PROVIDED IN THE COMPLAINT WAS NOT SUFFICIENT TO DETERMINE CONCLUSIVELY THE CAUSE OF THE REPORTED ISSUE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IT IS POSSIBLE THAT THE CIRCUMSTANCES OF THE PROCEDURE AND/OR THE MANIPULATION AND INTERACTION OF THE DEVICES MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00831.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE VENOUS FISTULA COILING PROCEDURE ON NORMAL VENOUS ANATOMY TARGETING THE TRANSVERSE SINUS, THE 8MM X 24CM GALAXY G3 COIL (GLY120824 / L10800) WAS REPORTED TO HAVE ISSUE ADVANCING FROM THE COIL INTRODUCER. THE COIL WAS FLUSHED AGAIN, BUT IT STILL DID NOT ADVANCE FROM THE COIL INTRODUCER. IT WAS REPORTED THAT THE END USER TRIED TO UNLOCK THE COIL FROM THE LOCKING TOOL, BUT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER. THE COIL DID NOT ENTER THE MICROCATHETER (EXCELSIOR¿ SL-10¿, STRYKER). IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED ON THE GALAXY G3 COIL; NO BEND OR KINKS WERE NOTED ON THE MICROCATHETER. THE GALAXY G3 COIL WAS REMOVED FROM THE PATIENT BUT THE MICROCATHETER WAS LEFT IN THE PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT CONSEQUENCE; THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE 8MM X 24CM GALAXY G3 COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988105 GALAXY G3 8MM X 24CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 L10800 10886704077589

    Patients

    Seq Age Sex Outcome Treatment
    1