BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 23262875 · Received October 9, 2025

    Report

    Report Number
    2032493-2025-90552
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 9, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U. S. AT THE TIME OF THIS REPORTING. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO V-TRAK HYDROSOFT 3D, 510(K): K161367). INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT FURTHER VERIFY IF THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EVALUATE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE THE PRESENCE OF ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AN ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: BASED ON A REVIEW OF THE LAST 2 YEARS OF COMPLAINT DATA, AND AT THE TIME OF THIS INVESTIGATION, NO SYSTEMIC ISSUES HAVE BEEN IDENTIFIED FOR THIS BATCH NUMBER THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): PLEASE REFER TO THE JAPANESE IFU FOR PRECAUTIONS, WARNINGS, AND FURTHER INFORMATION. THE FOLLOWING IS TAKEN FROM THE ENGLISH VERSION: 5.INTRODUCTION AND DEPLOYMENT OF THE COIL DELIVERY SYSTEM 5-3 SEAT THE DISTAL TIP OF THE INTRODUCER SHEATH AT THE DISTAL END OF THE MICROCATHETER HUB AND CLOSE THE RHV LIGHTLY AROUND THE INTRODUCER SHEATH TO SECURE THE RHV TO THE INTRODUCER SHEATH. CAUTION·DO NOT OVER-TIGHTEN THE RHV AROUND THE INTRODUCER SHEATH. [EXCESSIVE TIGHTENING COULD DAMAGE THE PUSHER CATHETER SUCH AS KINKING. ] 5-4 PUSH THE COIL INTO THE LUMEN OF THE MICROCATHETER. CAUTION·AVOID CATCHING THE COIL ON THE JUNCTION BETWEEN THE INTRODUCER SHEATH AND THE HUB OF THE MICROCATHETER. ·INITIATE TIMING USING A STOPWATCH OR TIMER AT THE MOMENT THE COIL ENTERS THE MICROCATHETER. 5-5 PUSH THE PUSHER CATHETER THROUGH THE MICROCATHETER UNTIL THE PROXIMAL END OF THE PUSHER CATHETER MEETS THE PROXIMAL END OF THE INTRODUCER SHEATH. LOOSEN THE RHV. RETRACT THE INTRODUCER SHEATH JUST OUT OF THE RHV. CLOSE THE RHV AROUND THE PUSHER CATHETER. CAUTION·AVOID KINKING THE PUSHER CATHETER AND INTRODUCER SHEATH. ·TO PREVENT PREMATURE HYDRATION OF THE AZUR SYSTEM, ENSURE THAT THERE IS FLOW FROM THE SALINE FLUSH. 5-7 UNDER FLUOROSCOPIC GUIDANCE, SLOWLY ADVANCE THE COIL INTO THE VESSEL/ANEURYSM FROM THE TIP OF THE MICROCATHETER. 5-8 CONTINUE TO ADVANCE THE COIL INTO THE LESION UNTIL OPTIMAL DEPLOYMENT IS ACHIEVED. REPOSITION IF NECESSARY. CAUTION·IF THE COIL SIZE IS NOT SUITABLE, REMOVE AND REPLACE WITH ANOTHER MORE APPROPRIATELY SIZED COIL. ·DO NOT ROTATE THE PUSHER CATHETER DURING OR AFTER DEPLOYMENT OF THE COIL INTO THE VESSEL/ANEURYSM. [ROTATING THE PUSHER CATHETER MAY RESULT IN A STRETCHED COIL OR PREMATURE DETACHMENT OF THE COIL FROM THE PUSHER CATHETER, WHICH COULD RESULT IN COIL MIGRATION.] INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COIL WAS UNPACKED FOR USE AS THE THIRD COIL. HOWEVER, WHEN THE COIL WAS ATTEMPTED TO BE INSERTED INTO A MICROCATHETER, RESISTANCE WAS FELT. UPON INSPECTION, IT WAS FOUND THAT THE IMPLANT HAD ALREADY DETACHED INSIDE THE MICROCATHETER THAT WAS WITHIN THE PATIENT. THE COIL WAS REMOVED FROM THE PATIENT ALONG WITH THE MICROCATHETER. ANOTHER COIL WAS THEN USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124023 AZUR SOFT3D DETACHABLE 10 DEVICE, NEUROVASCULAR EMBOLIZATION KRD MICROVENTION, INC. MV-HS00520 0000998626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AZUR SOFT3D, LOT# 0000998626.