BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 20221252 · Received September 15, 2024

    Report

    Report Number
    2032493-2024-00688
    Event Type
    Malfunction
    Date Received
    September 15, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 15, 2024
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    UDI-DI
    04987892128394
    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). VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WAS NOT PROVIDED FOR THIS INVESTIGATION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT DEFINITIVELY DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE'S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE 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. BATCH REVIEW: 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. 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. 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. INVESTIGATION CONCLUSION THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR 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 DEFINITIVELY DETERMINE 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 DURING A PEDIATRIC PV SHUNT CASE, THE COIL COULD NOT DETACH USING TWO DIFFERENT DETACHMENT CONTROLLERS AS THEY DISPLAYED A GREEN LED LIGHT BUT THEN BLINKED RED. A THIRD ATTEMPT WAS MADE TO DETACH THE COIL WITH A DIFFERENT DETACHMENT CONTROLLER, BUT IT HAD NO SUCCESS. THE COIL WAS THEN ATTEMPTED TO BE REMOVED AND UNINTENTIONALLY DETACHED. THEREFORE, THE IMPLANT WAS PUSHED USING THE PUSHER AND PLACED IN THE TARGET ARTERY. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563896 AZUR SOFT3D DETACHABLE 10 PERIPHERAL EMBOLIZATION DEVICE KRD MICROVENTION INC. MV-HS00415 0000485900 04987892128394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown