BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 22578076 · Received July 23, 2025

    Report

    Report Number
    2032493-2025-90352
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 17, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S., THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO V-TRAK HYDROSOFT 3D, 510(K): K161367). THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D10, H3, H6 AND H11. THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER BODYCOIL OFFSET/OVERLAPPING AT THE DISTAL END, THE PUSHER HYPOTUBE KINKED AT THE PROXIMAL SECTION, AND THE IMPLANT SEPARATED FROM THE PUSHER; HOWEVER, NO INDICATIONS OF ACTIVATION USING A DETACHMENT CONTROLLER WAS FOUND ON THE PUSHER HEATER COIL. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THE PUSHER'S MONOFILAMENT WITH A TENSILE BREAK SHAPE AT THE TIP, WHICH IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCE THAT EXCEEDED THE STRENGTH OF THE MONOFILAMENT CAUSING THE IMPLANT TO SEPARATE FROM THE PUSHER. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE PUSHER DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE PUSHER'S YIELD STRENGTH. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED RESISTANCE DURING COIL RETRIEVAL. THE DETACHMENT CONTROLLER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED DETACHMENT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COIL PASSED THE PRETEST NORMALLY, BUT WHEN THE DETACHMENT BUTTON WAS PUSHED TO PLACE THE IMPLANT, A RED LIGHT APPEARED. NO MATTER WHAT WAS ATTEMPTED, THE RED LIGHT APPEARED. WHEN THE COIL WAS ATTEMPTED TO BE RETRIEVED, THE PUSHER COULD BE PULLED, BUT THE COIL WAS STUCK IN THE MICROCATHETER AFTER THE COIL WAS SLIGHTLY RESHEATHED. THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER FROM THE PATIENT. WHEN THE GUIDING CATHETER WAS REMOVED, THE COIL CAME OUT TOO. THE IMPLANT WAS FOUND TO BE DETACHED, AND THE DETACHED IMPLANT WAS SUCCESSFULLY REMOVED FROM THE PATIENT BY REMOVING THE GUIDING CATHETER. ANOTHER COIL WAS USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS NO HEALTH DAMAGE.

    Description of Event or Problem · 0

    SEE H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768309 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00520 0000779226 04987892128431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AZUR V-GRIP.| UNKNOWN GUIDING CATHETER.| UNKNOWN MICROCATHETER.