BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24988200 · Received April 24, 2026

    Report

    Report Number
    2032493-2026-00279
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME THIS COMPLAINT WAS RECEIVED, THIS PRODUCT WAS AN EXPORTED DEVICE THAT WAS NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S. THE COMPLAINT IS BEING REPORTED NOW AS BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL WAS UNABLE TO ADVANCE IN THE MICROCATHETER. THE PUSHER HAD PREMATURELY SEPARATED INSIDE THE MICROCATHETER WHILE IN THE PATIENT. THE COIL SYSTEM WAS REMOVED FROM THE PATIENT AND FOUND THAT THE PUSHER COMPONENT HAD SEPARATED FROM THE COIL. NO COIL COMPONENTS WERE LEFT IN THE PATIENT. A NEW COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE PATIENT¿S CONDITION WAS REPORTED AS NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051523 AZUR SOFT3D DETACHABLE 10 DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00833 0001210631 04987892128523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown