BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 3MM X 4CM

    MDR report key: 17469628 · Received August 7, 2023

    Report

    Report Number
    3008114965-2023-00564
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 12, 2023
    Manufacturer
    CERENOVUS, INC.
    Product Code
    KRD
    UDI-DI
    10886704077688
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H10. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, A GALAXY G3 XSFT 3MM X 4CM COIL ((B)(6)) BECAME STRETCHED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE GALAXY G3 MINI 3MM X 4CM COIL WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE EMBOLIC COIL WAS FOUND PARTIALLY INSIDE THE INTRODUCER SHEATH; THE DISTAL PORTION WAS NOTED TO BE OUTSIDE. THE DEVICE WAS INSPECTED UNDER MICROSCOPIC MAGNIFICATION, AND IT WAS FOUND THAT THE EMBOLIC COIL WAS SEVERELY STRETCHED AND WAS STILL ATTACHED TO THE RESISTANCE HEATING (RH); THIS WAS FOUND NOT SOFTENED, INDICATING THAT THE DETACHMENT PROCESS WAS NOT INITIATED. ALSO, IT WAS NOTED THAT THE CORE WIRE WAS FOLDED INSIDE THE INTRODUCER TUBE. THE ISSUE REGARDING THE EMBOLIC COIL BEING STRETCHED WAS CONFIRMED BASED ON THE DAMAGES OBSERVED ON THE COIL. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUES FROM OCCURRING. ACCORDING TO THE RISK DOCUMENTATION, COIL DAMAGE IS A POTENTIAL ISSUE THAT CAN OCCUR DURING MICROCOIL PLACEMENT DUE TO THE ROTATIVE HEMOSTASIS VALVE (RHV) BEING FASTENED TOO TIGHTLY AND THE INTRODUCER TIP AND MICROCATHETER HUB BEING MISALIGNED. ALSO, FRICTION AND DIFFICULTY TO ADVANCE ARE POTENTIAL ISSUES THAT CAN OCCUR DURING MICROCOIL PLACEMENT DUE TO CONTINUOUS SALINE FLUSH NOT BEING ESTABLISHED, RESULTING IN COIL STRETCHING. HOWEVER, OTHER FACTORS NOT DESCRIBED IN THE EVENT DESCRIPTION MAY HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED DURING THE PROCEDURE. WITH THE LIMITED INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. THE FOLDED CONDITION OF THE CORE WIRE IS NOT ORIGINALLY REPORTED IN THE COMPLAINT, AND IT IS SUGGESTED THAT IT APPEARED DURING THE RETRACTION OF THE DEVICE; THIS CONDITION IS NOT CONSIDERED RELATED TO THE REPORTED ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30797246 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INDICATION: ¿ IF UNUSUAL FRICTION IS NOTED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE, AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. LOOSEN THE RHV MAIN VALVE AND FULLY RE-INSERT THE INTRODUCER TIP INTO THE INFUSION MICROCATHETER HUB. GENTLY TIGHTEN THE RHV MAIN VALVE AROUND THE INTRODUCER SHEATH TO PREVENT BACK-FLOW OF BLOOD. VISUALLY INSPECT THE ALIGNMENT OF THE INTRODUCER TIP AND THE MICROCATHETER HUB TO ENSURE THEY HAVE NOT SLIPPED APART. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF INFORMATION IS PROVIDED AT A LATER DATE, THE FILE WILL BE REOPENED AND PROCESSED ACCORDINGLY. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D2B ¿ PROCODE: KRD/HCG. SECTION H3 - 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. 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, A GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304, 30797246) BECAME STRETCHED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637421 GALAXY G3 XSFT 3MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD CERENOVUS, INC. 30797246 10886704077688

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female