BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 18800095 · Received February 28, 2024

    Report

    Report Number
    2032493-2024-00172
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 28, 2024
    Manufacturer
    MICROVERSION, 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 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). INVESTIGATION SUMMARY: 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-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 AND 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 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 THE AZUR COIL WAS USED IN AN UNSPECIFIED EMBOLIZATION PROCEDURE. DURING PLACEMENT THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE CATHETER ALONG WITH THE COIL WERE WITHDRAWN AND REMOVED FROM THE PATIENT. THE COIL WAS REPLACED WITH ANOTHER COIL THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733603 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVERSION, INC. MV-HS01504 0000445839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown