BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 3MM X 4CM

    MDR report key: 7795587 · Received August 17, 2018

    Report

    Report Number
    3008114965-2018-00717
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    May 23, 2018
    Report Date
    August 17, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077688
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT 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)(6)). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY, THE GALAXY G3 XSFT COIL 3MM X 4CM (GLX120304 / L10820) WAS SELECTED AS THE FIRST COIL USE IN THE PROCEDURE. WHEN THE SLEEVE WAS UNLOCKED TO DELIVER THE COIL INTO THE INTO THE MICROCATHETER, THE TIP OF THE SHEATH HAD A CUT AND AS A RESULT, THE COIL COULD NOT BE DELIVERED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER DELAY OR ISSUE. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE; THE COIL INTRODUCER WAS NOT TORN AND THERE WAS NO RESISTANCE ENCOUNTERED BETWEEN THE GALAXY G3 COIL AND THE MICROCATHETER. 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). THE GALAXY G3 COIL WAS RETURNED FOR INVESTIGATION; THE COIL WAS FOUND STRETCHED AND WITH MULTIPLE KINKS. THE INVESTIGATIONAL FINDINGS MEET FDA REPORTING CRITERIA. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL ADVANCED OUT OF THE INTRODUCER AND TANGLED AROUND THE DEVICE POSITIONING UNIT (DPU) CORE WIRE. THE EMBOLIC COIL WAS GENTLY DISENTANGLED FROM THE DPU CORE WIRE. THE TRANSLUCENT INTRODUCER SHEATH APPEARS TO BE CAUGHT IN THE V-NOTCH OF THE RESHEATHING TOOL, AND ITS PROXIMAL END APPEARS TO BE TORN OFF. THE DPU CORE WIRE IS KINKED NEAR 28 CM, 81 CM, AND 108 CM FROM THE PROXIMAL END. THE BALL TIP WAS OBSERVED TO BE INTACT. MULTIPLE KINKS WERE OBSERVED IN THE EMBOLIC COIL. THE EMBOLIC COIL WAS STRETCHED AT ITS PROXIMAL END, NEAR THE ARTICULATING JOINT. THE ARTICULATING JOINT APPEARS TO BE UNDAMAGED. THE DISTAL OUTER SHEATH HAS NOT SOFTENED, INDICATING THAT THE RESISTANCE HEATING (RH) HAS NOT HEATED. THE EXTENDED COIL WAS OBSERVED TO BE DAMAGED. THE TRANSLUCENT INTRODUCER SHEATH IS TORN LENGTHWISE. A PORTION OF IT IS CAUGHT IN THE V-NOTCH OF THE RESHEATHING TOOL. THE OTHER PORTION HAS BEEN TORN OFF CLOSE TO THE V-NOTCH. THE V-NOTCH IS FRACTURED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L10820) 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 COMPLAINT THAT THE INTRODUCER IS DAMAGED IS CONFIRMED. THE TRANSLUCENT INTRODUCER SHEATH IS TORN. A PORTION OF IT IS CAUGHT IN THE FRACTURED V-NOTCH OF THE RESHEATHING TOOL, AND THE OTHER PORTION HAS BEEN TORN OFF AT THE FRACTURE. THE FRACTURED V-NOTCH INDICATES THAT THE DEVICE WAS NOT PROPERLY UNLOCKED PRIOR TO USE. THE IFU (LCN 208534-001 REV. A) INSTRUCTS THE USER TO UNLOCK THE DEVICE BY GENTLY PULLING THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE-SHEATHING TOOL AT A 45-DEGREE ANGLE. PULLING THE TAB STRAIGHT OUT (IN PARALLEL TO THE DPU) WILL RESULT IN DAMAGE TO THE RESHEATHING TOOL AND MAY ALSO RESULT IN DAMAGE TO THE EMBOLIC COIL. IN THIS CASE, THE TRANSLUCENT INTRODUCER SHEATH APPEARS TO HAVE BEEN CAUGHT IN THE FRACTURE, AND APPLICATION OF EXCESSIVE FORCE CAUSED THE SHEATH TO TEAR AND A PORTION OF IT TO TEAR OFF. UNSHEATHING AND RESHEATHING IS TESTED ON 100% OF DEVICES WHEN THE RESHEATHING TOOL IS ATTACHED TO THE DEVICE AND THE INTRODUCER LOCK IS FORMED PER MPS-PRP0169 REV. 10. THUS, IT IS VERY UNLIKELY THAT THE OBSERVED DAMAGE TO THE TRANSLUCENT INTRODUCER SHEATH AND RESHEATHING TOOL WAS PRESENT WHEN THE DEVICE LEFT THE MANUFACTURING FACILITY. KINKS IN THE EMBOLIC COIL MAY HAVE OCCURRED AS A RESULT OF THE EXCESSIVE FORCE APPLIED TO THE INTRODUCER, OR IT MAY HAVE OCCURRED AFTER THE PROCEDURE, AS THE DEVICE WAS PREPARED FOR STORAGE AND/OR RETURN. LIKEWISE, STRETCHING OF THE EMBOLIC COIL COULD HAVE OCCURRED DURING THE PROCEDURE, AS THE DEVICE WAS BEING REMOVED, OR AS THE DEVICE WAS PREPARED FOR STORAGE AND/OR RETURN. 100% OF DEVICES ARE INSPECTED FOR DAMAGE TO THE EMBOLIC COIL AT FINAL ASSEMBLY PER 103002467 REV. 12. IN ADDITION, COIL LENGTH IS MEASURED AT FINAL QUALITY CONTROL (QC) INSPECTION PER 103168373 REV. 4. A STRETCHED EMBOLIC COIL WOULD BE REJECTED AT THIS STEP. THUS, IT IS VERY UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE TO THE EMBOLIC COIL. DEVICE HISTORY LOT ==> A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L L10820) 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. WITH THE INFORMATION PROVIDED IN THE COMPLAINT AND THE RETURNED GALAXY G3 COIL FOR PRODUCT EVALUATION, ANALYSIS FINDING CONFIRMED THAT THE COIL INTRODUCER WAS DAMAGED, THE CONDITION OF THE DAMAGE INDICATES THAT THE CAUSE WAS LIKELY DUE TO THE DEVICE NOT BEING PROPERLY UNLOCKED PRIOR TO USE. THE EMBOLIC COIL WAS ALSO KINKED IN MULTIPLE PLACES AND WAS STRETCHED AT ITS PROXIMAL END. THE LIKELY CAUSE WAS APPLIED EXCESSIVE FORCE TO THE INTRODUCER. THE CAUSE COULD HAVE OCCURRED AFTER THE PROCEDURE AS THE DEVICE WAS BEING PREPARED FOR RETURN. THE STRETCHED CONDITION OBSERVED NEAR THE PROXIMAL END COULD HAVE OCCURRED DURING THE PROCEDURE AS THE COIL WAS BEING REMOVED OR DURING PREPARATION FOR THE DEVICE RETURN. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% TESTING FOR RESISTANCE AFTER BEING LOADED INTO THE PACKAGING HOOP. IN ADDITION, 100% OF DEVICES UNDERGO INSPECTION FOR DAMAGE TO THE EMBOLIC COIL AT FINAL ASSEMBLY. COIL LENGTH IS ALSO MEASURED AT FINAL QUALITY INSPECTION. THUS, IT IS NOT LIKELY THAT THE GALAXY G3 XSFT COIL 3MM X 4CM LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGES TO 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. 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 OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY, THE GALAXY G3 XSFT COIL 3MM X 4CM (GLX120304 / L10820) WAS SELECTED AS THE FIRST COIL USE IN THE PROCEDURE. WHEN THE SLEEVE WAS UNLOCKED TO DELIVER THE COIL INTO THE INTO THE MICROCATHETER, THE TIP OF THE SHEATH HAD A CUT AND AS A RESULT, THE COIL COULD NOT BE DELIVERED. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER DELAY OR ISSUE. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE; THE COIL INTRODUCER WAS NOT TORN AND THERE WAS NO RESISTANCE ENCOUNTERED BETWEEN THE GALAXY G3 COIL AND THE MICROCATHETER. 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). THE PRODUCT WAS INDICATED AS AVAILABLE TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636012 GALAXY G3 XSFT 3MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 L10820 10886704077688

    Patients

    Seq Age Sex Outcome Treatment
    1