BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24472044 · Received February 27, 2026

    Report

    Report Number
    2032493-2026-00136
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 19, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS RECEIVED. H6: IMPACT CODE 4580 WAS UPDATED TO 4582 BASED ON ADDITIONAL INFORMATION. H11: THE ADDITIONAL PATIENT INFORMATION PROVIDED DOES NOT HAVE ANY IMPACT ON THE INVESTIGATIVE DATA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO INCLUDE THE ADDITIONAL INFORMATION RECEIVED.

    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). 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

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S CONDITION IS STABLE. SEE H6 & H11.

    Description of Event or Problem · 0

    AS REPORTED: TO EMBOLIZE A BRONCHIAL ARTERY ANEURYSM, A CATHETER WAS DELIVERED VIA THE BRACHIAL ARTERY. AFTER EMBOLIZATION OF THE TARGET SITE, A FINAL ANGIOGRAPHY WAS PERFORMED AND SHOWED THAT THERE WAS SOMETHING THAT LOOKED LIKE A STRETCHED IMPLANT AROUND THE PROCEDURAL INTRODUCER SHEATH. THE PHYSICIAN DECIDED NOT TO PERFORM ADDITIONAL TREATMENT AND TO PLACE THE PATIENT UNDER OBSERVATION BECAUSE HE WAS CONCERNED THAT THE PATIENT'S CONDITION COULD WORSEN IF THE STRETCHED IMPLANT WERE REMOVED. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE OUR SALES REPRESENTATIVE SPEAKS WITH THE PHYSICIAN. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE BRONCHIAL ARTERY ANEURYSM WAS LOCATED BEYOND SEVERAL LOOPS OF THE VESSEL. THE PROCEDURE WAS PERFORMED USING A TRIPLE COAXIAL SYSTEM CONSISTING OF AN ANGIOGRAPHY CATHETER, A COMPETITOR MICROCATHETER, AND A SMALLER MICROCATHETER. AFTER THE MICROCATHETERS WERE DELIVERED TO THE TARGET SITE, THE FIRST COIL WAS INSERTED. HOWEVER, IT WAS DIFFICULT TO ADVANCE THE COIL OUT OF THE DISTAL TIP OF THE MICROCATHETER, CAUSING THE IMPLANT TO UNINTENTIONALLY DETACH WITHIN THE MICROCATHETER. THE IMPLANT WAS THEN SUCCESSFULLY PLACED BY PUSHING THE IMPLANT WITH SALINE. AFTER THE COIL IN QUESTION WAS POSITIONED IN THE VESSEL ON THE PROXIMAL SIDE OF THE ANEURYSM, THE IMPLANT WAS DETACHED. HOWEVER, WHEN THE PHYSICIAN PULLED THE PUSHER, HE FELT SOMETHING CUT OFF. AFTER THAT, IT BECAME IMPOSSIBLE TO INSERT A MICRO GUIDEWIRE INTO THE MICROCATHETER. ALL OF THE CATHETERS, ANGIOGRAPHY CATHETER, MICROCATHETER, AND SMALLER MICROCATHETER. WERE REPLACED WITH DIFFERENT CATHETERS. AFTER REPLACING THEM, THE PHYSICIAN NOTICED A PIECE OF THE STRETCHED IMPLANT AROUND THE TIP OF THE CATHETER. ANGIOGRAPHY PERFORMED VIA THE PROCEDURAL INTRODUCER SHEATH REVEALED THAT A PORTION OF THE DETACHED IMPLANT HAD STRETCHED AND WAS EXTENDING OUTSIDE THE TARGET VESSEL. THE PHYSICIAN DETERMINED THAT ATTEMPTING TO RETRIEVE THE DETACHED IMPLANT WOULD LIKELY WORSEN THE SITUATION. THEREFORE, IT WAS DECIDED THAT THE PATIENT WAS PLACED UNDER OBSERVATION. THE CASE WAS COMPLETED WITHOUT ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269729 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00410 0000608297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ESTREAM T3 MICROCATHETER (TORAY MEDICAL).