BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 25129562 · Received May 8, 2026

    Report

    Report Number
    2032493-2026-00307
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128523
    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 US. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (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 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. 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: 6.DETACHMENT OF THE COIL 6-1 PLACE THE DETACHMENT CONTROLLER REMOVED FROM THE PROTECTIVE PACKAGING IN A CLEAN FIELD. CAUTION·DO NOT DETACH THE COIL USING ANY POWER SOURCE OTHER THAN THE DETACHMENT CONTROLLER. 6-2 CONNECT THE PROXIMAL END OF THE PUSHER CATHETER TO THE DETACHMENT CONTROLLER BY FIRMLY INSERTING THE PROXIMAL END OF THE PUSHER CATHETER INTO THE FUNNEL SECTION OF THE DETACHMENT CONTROLLER. OBSERVE THE STATE OF THE LIGHT 3 SECONDS AFTER CONNECTING.(SEE FIGURE 1) CAUTION ·IF THE PUSHER CATHETER IS NOT CONNECTED PROPERLY, THE CONTROLLER WILL NOT ACTIVATE. ·SINCE THE CONTROLLER DOES NOT HAVE AN ON/OFF SWITCH, DO NOT PRESS THE SIDE BUTTON OF THE DETACHMENT CONTROLLER. ·KEEP BLOOD AND CONTRAST AWAY FROM THE PROXIMAL END OF PUSHER CATHETER. IF THERE APPEARS TO BE BLOOD OR CONTRAST, WIPE WITH STERILE WATER OR HEPARINIZED SALINE SOLUTION BEFORE CONNECTING TO THE DETACHMENT CONTROLLER.[DETACHMENT CONTROLLER MAY NOT WORK PROPERLY.] IF A RED LIGHT APPEARS OR IF THE LIGHT DOES NOT APPEAR, REPLACE THE DETACHMENT CONTROLLER. 6-3 WHEN THE DETACHMENT CONTROLLER IS PROPERLY CONNECTED TO THE PUSHER CATHETER, A SINGLE AUDIBLE TONE WILL SOUND AND THE LIGHT WILL TURN GREEN TO SIGNAL THAT IT IS READY TO DETACH THE COIL. 6-5 PUSH THE DETACHMENT BUTTON TO DETACH AND DEPLOY COIL. WHEN THE BUTTON IS PUSHED, AN AUDIBLE TONE WILL SOUND AND THE LIGHT WILL FLASH GREEN. 6-6 AT THE END OF THE DETACHMENT CYCLE, THREE AUDIBLE TONES WILL SOUND AND THE LIGHT WILL FLASH YELLOW THREE TIMES. THIS INDICATES THAT THE DETACHMENT CYCLE IS COMPLETE. VERIFY DETACHMENT OF THE COIL BY FIRST LOOSENING THE RHV VALVE, THEN PULLING BACK SLOWLY ON THE DELIVERY SYSTEM AND VERIFYING THAT THERE IS NO COIL MOVEMENT. IF THE COIL DOES NOT DETACH DURING THE DETACHMENT CYCLE, RE-INSERT THE PUSHER CATHETER INTO THE CONTROLLER AND ATTEMPT ANOTHER DETACHMENT CYCLE WHEN THE LIGHT TURNS GREEN. CAUTION·THE LIGHT WILL TURN RED AFTER THE 20 CYCLES OF DETACHMENT, SO IF THE RED LIGHT COMES ON BEFORE THE DETACHMENT OPERATION, DISCARD THE DETACHMENT CONTROLLER AND REPLACE IT WITH A NEW ONE. IF IT DOES NOT DETACH AFTER THE THIRD ATTEMPT, REMOVE THE DELIVERY SYSTEM AND REPLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, AFTER DEPLOYING THE COIL WITHIN THE ANEURYSM THROUGH A MICROCATHETER, THE IMPLANT WAS DETACHED. SINCE THE PUSHER WAS SUCCESSFULLY REMOVED FROM THE PATIENT, THE PHYSICIAN BELIEVED THAT THERE WERE NO ISSUES. HOWEVER, WHEN FLUOROSCOPY CONTINUED, IT SHOWED THAT THE IMPLANT APPEARED STRETCHED. UNDER FLUOROSCOPY, THE FILAMENT OF THE STRETCHED IMPLANT WAS NOT OBSERVED STRETCHING TO THE AORTA TRUNK. THEREFORE, THE PHYSICIAN CONCLUDED THAT THE COIL WAS PLACED WITHOUT ISSUE. THEN, THE NEXT COIL WAS USED TO CONTINUE THE PROCEDURE. EMBOLIZATION OF THE TARGET SITE WAS FINISHED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338809 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00833 0001047047 04987892128523

    Patients

    Seq Age Sex Outcome Treatment
    1