BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24931139 · Received April 20, 2026

    Report

    Report Number
    2032493-2026-00267
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 20, 2026
    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 DEVICE 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 DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COIL COULD NOT BE SMOOTHLY ADVANCED IN A MICROCATHETER. THE COIL WAS REMOVED FROM THE MICROCATHETER ONCE. HOWEVER, DURING THE SECOND ATTEMPT, THE PUSHER BECAME SEPARATED. THE COIL WAS WITHDRAWN ALONG WITH THE MICROCATHETER, LEAVING NO COIL COMPONENT IN THE PATIENT. ANOTHER COIL WAS THEN USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240595 AZUR SOFT3D DETACHABLE 10 DEVICE FOR NEUROVASCULAR EMBOLIZATION KRD MICROVENTION, INC. MV-HS00415 0000576585 04987892128394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown