BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24195677 · Received January 27, 2026

    Report

    Report Number
    2032493-2026-00038
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THAT THE IMPLANT WAS SEPARATED FROM THE PUSHER; HOWEVER, NO INDICATIONS OF ACTIVATION USING A DETACHMENT CONTROLLER WAS FOUND ON THE PUSHER HEATER COIL. FURTHER INSPECTION FOUND THE PUSHER HYPO TUBE KINKED AT THE DISTAL SECTION. THE IMPLANT WAS NOT RETURNED FOR EVALUATION; FURTHERMORE, THE ATTACHMENT MONOFILAMENT WAS NOT PRESENT IN THE PUSHER. WITHOUT THE RETURN AND EVALUATION OF THE IMPLANT AND MONOFILAMENT, THE INVESTIGATION IS UNABLE TO DETERMINE THE MODE OF SEPARATION (I.E., UNINTENTIONAL VS NORMAL DETACHMENT USING A DETACHMENT CONTROLLER). THE INVESTIGATION COULD NOT VERIFY THE MODE OF IMPLANT SEPARATION DUE TO THE ABSENCE OF THE IMPLANT AND MONOFILAMENT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE KINKED PUSHER, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING THE IMPLANT¿S YIELD STRENGTH. THE RETURNED MICROCATHETER WAS FOUND FLATTENED AT 2CM FROM THE DISTAL TIP; HOWEVER, NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE LUMEN, AND AN IN-HOUSE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE LUMEN WITHOUT RESISTANCE DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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). 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. THE COIL WAS IMPLANTED IN THE PATIENT, AND THE PUSHER WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED DESPITE ATTEMPTS MADE. ADDITIONAL DUE DILIGENCE ATTEMPTS ARE ONGOING. THE ALLEGED PRODUCT ISSUE/EVENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE PUSHER IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    SEE H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COIL WAS ATTEMPTED TO BE USED AS THE FINISHING COIL DURING AN ANEURYSM TREATMENT. DURING BALLOON ASSISTED COILING, THE COIL WAS DEPLOYED OUTSIDE THE ANEURYSM THROUGH THE GAB BETWEEN THE VESSEL AND THE DISPLACED BALLOON, POSSIBLY DUE TO AN UNNOTICED MOVEMENT OF THE BALLOON. WHILE THE COIL WAS BEING PUSHED AND PULLED REPEATEDLY FOR REPOSITIONING, THE COIL STOPPED MOVING IN UNISON WITH THE PUSHER, INDICATING UNINTENDED DETACHMENT OF THE IMPLANT. SUBSEQUENTLY, UPON WITHDRAWING THE PUSHER FROM THE COMPETITOR¿S MICROCATHETER, A PORTION OF THE IMPLANT (APPROXIMATELY 3CM) REMAINED WITHIN THE COMPETITOR¿S MICROCATHETER TIP AND THE REMAINING PORTION WITHIN THE ANEURYSM. AN ATTEMPT WAS MADE TO PUSH THE ENTIRE IMPLANT INTO THE ANEURYSM WITH A GUIDEWIRE. HOWEVER, THE GUIDEWIRE BECAME STUCK IN THE COMPETITOR¿S MICROCATHETER DUE TO AN UNKNOWN FOREIGN OBJECT PRESENT IN THE PROXIMAL PORTION OF THE COMPETITOR¿S MICROCATHETER, PREVENTING THE GUIDEWIRE FROM REACHING THE IMPLANT. ANOTHER ATTEMPT TO PUSH THE IMPLANT INTO THE ANEURYSM USING SALINE FLUSHES ALSO FAILED BECAUSE THE FOREIGN OBJECT OBSTRUCTED THE FLOW OF SALINE. WHEN THE COMPETITOR'S MICROCATHETER WAS REMOVED FROM THE PATIENT, THE UNRAVELED COIL EXTENDED OUT OF THE ANEURYSM TO THE HEPATIC ARTERY IN THE STATE OF FILAMENT. AFTER CONFIRMING THAT THE UNRAVELED COIL DID NOT EXTEND TO THE AORTA, THE PROCEDURE WAS COMPLETED. THE PATIENT¿S CONDITION WAS REPORTED AS HAVING NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399691 AZUR SOFT3D DETACHABLE 10 DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00520 0001055095 04987892128431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O