BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT HEL 2MM X 8CM

    MDR report key: 7993480 · Received October 22, 2018

    Report

    Report Number
    3008114965-2018-00768
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 4, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077763
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). E.1: INITIAL REPORTER PHONE: (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE POST STENT GRAFT ENDOLEAK COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ILIOLUMBAR ARTERY, AFTER THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL (GLX120208 / L12103) ADVANCED THROUGH THE MICROCATHETER (MARVEL, TOKAI MEDICAL PRODUCTS) AND WAS READY TO BE PLACED, IT COULD NOT BE DETACHED. THE DETACHMENT BUTTON ON THE DETACHMENT CONTROL BOX WAS PRESSED, THE POWER LAMP THAT HAD ORIGINALLY ILLUMINATED DURING THE PREPARATION DID NOT ILLUMINATE. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE PHYSICIAN COMMENTED THAT THERE WAS STRONG RESISTANCE EXPERIENCED DURING THE INSERTION OF THE GALAXY G3 COIL INTO THE MICROCATHETER; THE RESISTANCE MIGHT HAVE FRACTURED THE WIRE IN FRONT OF THE Y-CONNECTOR AS THE DEVICE POSITIONING UNIT (DPU) WAS PUSHED DURING THE ADVANCEMENT. THE GALAXY G3 COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR PRODUCT EVALUATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12103) 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. 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. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE POST STENT GRAFT ENDOLEAK COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ILIOLUMBAR ARTERY, AFTER THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL (GLX120208 / L12103) ADVANCED THROUGH THE MICROCATHETER (MARVEL, TOKAI MEDICAL PRODUCTS) AND WAS READY TO BE PLACED, IT COULD NOT BE DETACHED. THE DETACHMENT BUTTON ON THE DETACHMENT CONTROL BOX WAS PRESSED, THE POWER LAMP THAT HAD ORIGINALLY ILLUMINATED DURING THE PREPARATION DID NOT ILLUMINATE. THE PHYSICIAN COMMENTED THAT THERE WAS STRONG RESISTANCE EXPERIENCED DURING THE INSERTION OF THE GALAXY G3 COIL INTO THE MICROCATHETER; THE RESISTANCE MIGHT HAVE FRACTURED THE WIRE IN FRONT OF THE Y-CONNECTOR AS THE DEVICE POSITIONING UNIT (DPU) WAS PUSHED DURING THE ADVANCEMENT. THE GALAXY G3 COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR PRODUCT EVALUATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12103) 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. 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. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE POST STENT GRAFT ENDOLEAK COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ILIOLUMBAR ARTERY, AFTER THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL (GLX120208 / L12103) ADVANCED THROUGH THE MICROCATHETER (MARVEL, TOKAI MEDICAL PRODUCTS) AND WAS READY TO BE PLACED, IT COULD NOT BE DETACHED. THE DETACHMENT BUTTON ON THE DETACHMENT CONTROL BOX WAS PRESSED, THE POWER LAMP THAT HAD ORIGINALLY ILLUMINATED DURING THE PREPARATION DID NOT ILLUMINATE. THE PHYSICIAN COMMENTED THAT THERE WAS STRONG RESISTANCE EXPERIENCED DURING THE INSERTION OF THE GALAXY G3 COIL INTO THE MICROCATHETER; THE RESISTANCE MIGHT HAVE FRACTURED THE WIRE IN FRONT OF THE Y-CONNECTOR AS THE DEVICE POSITIONING UNIT (DPU) WAS PUSHED DURING THE ADVANCEMENT. THE GALAXY G3 COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE GALAXY G3 XSFT HELICAL 2MM X 8CM COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829124 GALAXY G3 XSFT HEL 2MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 L12103 10886704077763

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (MARVEL, TOKAI MEDICAL PRODUCTS)