BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 2.5MM X 5CM

    MDR report key: 8164938 · Received December 14, 2018

    Report

    Report Number
    3008114965-2018-00838
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077626
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH MEDIUM VESSEL TORTUOSITY, THE PHYSICIAN PICKED THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L11429) AND INTRODUCED THE COIL USING THE PROWLER 14 MICROCATHETER INTO THE PATIENT, THE COIL SIZE WAS NOT CORRECT, AND THE PHYSICIAN DECIDED TO RESHEATH THE COIL; THE COIL COULD NOT BE RESHEATHED AND AS A RESULT, THE COIL COULD NO LONGER BE USED. ANOTHER COIL WAS SELECTED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT; IT WAS REPORTED THAT THE PATIENT WOKE UP AND HAD GREAT RESULT FROM THE PROCEDURE. THE GALAXY G3 COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE 2.5MM X 5CM GALAXY G3 XSFT COIL WAS RETURNED WITH ITS ORIGINAL PACKAGING, WHICH MATCHED THE COMPLAINT INFORMATION. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL ADVANCED FROM THE INTRODUCER SHEATH. A KINK WAS OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AT APPROXIMATELY 71 CM FROM THE PROXIMAL END OF THE DEVICE. THE DISTAL END OF THE DPU CORE WIRE EXITED THE DISTAL END OF THE RESHEATHING TOOL AND DID NOT ENTER BACK INTO THE INTRODUCER SHEATH LEAVING THE COIL EXPOSED. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. MULTIPLE KINKS WERE OBSERVED ALONG THE LENGTH OF THE EMBOLIC COIL. THE ARTICULATING JOINT WAS SEEN INTACT. IT WAS OBSERVED THAT THE DISTAL OUTER SHEATH HAD NOT SOFTENED INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT HEATED, AND THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE SKIVE OF THE DISTAL END OF THE TRANSLUCENT INTRODUCER WAS SEEN WITH A WIDENED GAP. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11429) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED THE COMPLAINT. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE REPORTED ISSUE THAT THE COIL INTRODUCER HAD ISSUE WITH RESHEATHING WAS CONFIRMED. THE DPU CORE WIRE AND THE EMBOLIC COIL WERE COMPLETELY REMOVED FROM THE COIL INTRODUCER, EVEN THOUGH BOTH THE DPU AND THE COIL INTRODUCER TRAVELED THROUGH THE RESHEATHING TOOL. THE EVENT DESCRIPTION STATED THAT THE DEVICE WAS INSERTED INTO THE PATIENT BUT HAD TO BE RESHEATHED WHEN IT WAS DETERMINED TO BE OF THE WRONG SIZE. IT IS LIKELY THAT THE EMBOLIC COIL SUSTAINED DAMAGE IN THE OBSERVED MULTIPLE KINKS OCCURRED DURING PLACEMENT OR RETRACTION OF THE DEVICE DUE TO THE ISSUE/DIFFICULTY ENCOUNTERED DURING THE ATTEMPT TO RESHEATH. THE INSTRUCTION FOR USE (IFU) PROVIDES INSTRUCTIONS FOR PROPER DELIVERY AND RESHEATHING OF THE DEVICE. THE IFU ALSO CAUTIONS AGAINST APPLYING EXCESSIVE FORCE WHICH MAY RESULT IN DAMAGE TO THE EMBOLIC COIL. DEVICES UNDERGO 100% IN-PROCESS INSPECTION AND FOR ZIPPING FUNCTIONALITY IS VERIFIED. THE EMBOLIC COILS AND INTRODUCERS UNDERGO INSPECTION; THE MULTIPLE KINKS OBSERVED ON THE EMBOLIC COIL WOULD HAVE BEEN CAUGHT DURING INSPECTION AT FINAL ASSEMBLY. IT IS UNLIKELY THAT THE 2.5MM X 5CM GALAXY G3 XSFT COIL LEFT THE MANUFACTURING FACILITY WITH THE DAMAGES / KINKS OBSERVED ON THE EMBOLIC COIL. COIL DAMAGE SUCH AS KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE IFU CONTAINS INSTRUCTIONS ON PROPER HANDLING OF THE DEVICE. THE REPORTED ISSUES CAPTURED IN THE COMPLAINT RELATED TO THE RESHEATHING DIFFICULTY WAS CONFIRMED DURING THE EVALUATION PERFORMED ON THE RETURNED DEVICE. 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 COIL DAMAGE / KINK CANNOT BE CONCLUSIVELY DETERMINED, THE DAMAGE COULD HAVE BEEN SUSTAINED DURING THE PLACEMENT OR RETRACTION OF THE DEVICE DUE TO THE DIFFICULTY ENCOUNTERED DURING THE RESHEATHING ATTEMPT WHERE EXCESSIVE FORCE MIGHT HAVE INADVERTENTLY BEEN APPLIED ON THE COIL. DEVICE HANDLING, DEVICE MANIPULATION/INTERACTION MAY ALSO CONTRIBUTED TO THE OBSERVED KINKS ON THE EMBOLIC COIL. 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.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH MEDIUM VESSEL TORTUOSITY, THE PHYSICIAN PICKED THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L11429) AND INTRODUCED THE COIL USING THE PROWLER 14 MICROCATHETER INTO THE PATIENT, THE COIL SIZE WAS NOT CORRECT, AND THE PHYSICIAN DECIDED TO RESHEATH THE COIL; THE COIL COULD NOT BE RESHEATHED AND AS A RESULT, THE COIL COULD NO LONGER BE USED. ANOTHER COIL WAS SELECTED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT; IT WAS REPORTED THAT THE PATIENT WOKE UP AND HAD GREAT RESULT FROM THE PROCEDURE. THE GALAXY G3 COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005575 GALAXY G3 XSFT 2.5MM X 5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 L11429 10886704077626

    Patients

    Seq Age Sex Outcome Treatment
    1