BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24915213 · Received April 17, 2026

    Report

    Report Number
    2032493-2026-00258
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 17, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    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 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 EVALUATION BUT IT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS PLACED AND DETACHED, BUT WHEN THE MICROCATHETER WAS ATTEMPTED TO BE REMOVED, THE IMPLANT, WHICH WAS SUPPOSED TO HAVE DETACHED, STRETCHED AND CAME ALONG WITH MICROCATHETER. TO RETRIEVE THE COIL, THE IMPLANT WAS CAPTURED USING A SNARE THROUGH THE MICROCATHETER. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED TO CONTINUE THE PROCEDURE, WHICH WAS SUCCESSFULLY COMPLETED. THE PATIENT'S CONDITION WAS REPORTED TO BE "NO HEALTH DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406829 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00310 0001019248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARRY LEON MICROCATHETER (1.9 FR, UTM)