BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 25321481 · Received May 28, 2026

    Report

    Report Number
    2032493-2026-00338
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    04987892128431
    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 THE REPORTED 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 RECEIVED. THE ALLEGED DETACHMENT ISSUE, REMOVAL DIFFICULTY AND INCIDENT 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

    AS REPORTED TO MICROVENTION: AFTER IMPLANTING THE FIRST COIL, THIS AZUR SOFT3D COIL WAS INSERTED INTO A MICROCATHETER TO BE USED AS THE SECOND COIL. HOWEVER, WHILE INSERTING THE COIL, RESISTANCE WAS FELT. WHEN THE COIL WAS WITHDRAWN, THE COIL GOT TANGLED WITH THE FIRST COIL THAT HAD BEEN IMPLANTED, AND BOTH COILS WERE REMOVED FROM THE PATIENT. SINCE THE SECOND COIL STILL APPEARED TO BE USABLE, THE COIL WAS REINSERTED INTO THE MICROCATHETER. HOWEVER, THE PUSHER BECAME SEPARATED INSIDE THE MICROCATHETER, AND THE DISTAL PART OF THE COIL WAS LEFT IN THE MICROCATHETER. AFTERWARDS, THE REMAINING COIL WAS WITHDRAWN ALONG WITH THE MICROCATHETER AND SUCCESSFULLY RETRIEVED FROM THE PATIENT. ANOTHER COIL WAS THEN USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HEALTH DAMAGE. NO OTHER INCIDENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149455 AZUR SOFT3D DETACHABLE 10 DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICROVENTION, INC. MV-HS00520 0001107192 04987892128431

    Patients

    Seq Age Sex Outcome Treatment
    1