BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 21654171 · Received March 20, 2025

    Report

    Report Number
    2032493-2025-00235
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 20, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128349
    Adverse Event
    Yes
    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 EXPORT DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE US. THIS COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO V-TRAK HYDROSOFT 3D, 510(K)#: K161367). THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO 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. A SEARCH FOR NON-CONFORMANCE'S 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. 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. 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-CONFORMANCE'S. 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. 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].

    Description of Event or Problem · 0

    AS REPORTED THE IMPLANT WAS EARLY DETACHED. THE COIL CONCERNED WAS ATTEMPTED TO BE IMPLANTED AFTER A COMPETITOR¿S COIL WAS IMPLANTED. THE V-GRIP DETACHMENT CONTROLLER WAS USED TO DETACH THE IMPLANT AS THE SECOND COIL, BUT THE V-GRIP DID NOT DETACH THE IMPLANT AS THE V-GRIP DID NOT RESPOND WHEN THE PUSHER END WAS INSERTED INTO THE V-GRIP. WHILE PUSHING AND PULLING THE COIL FOR POSITIONING NEAR THE TARGET SITE, THE IMPLANT DETACHED UNINTENTIONALLY. THE IMPLANT WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A SNARE. ANOTHER COMPETITOR¿S COIL WAS SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CORONARY ARTERY WAS TREATED. THE DEVICE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR RETURN AND ANALYSIS. THE PATIENT OUTCOME IS REPORTED AS "NO HEALTH DAMAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493287 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00310 0000592140 04987892128349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention AZUR VGRIP CONTROLLER.| HEADWAY MICROCATHETER.