BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24784114 · Received April 3, 2026

    Report

    Report Number
    2032493-2026-00225
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 3, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128349
    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 US. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (V-TRAK HYDROSOFT 3D, 510(K): K161367). A SEARCH FOR NON-CONFORMANCE'S 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 PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.

    Description of Event or Problem · 0

    AS REPORTED: IMPLANT WAS NOT DETACHED / IMPLANT STRETCHED. DUE TO THE VESSEL¿S SEVERE TORTUOSITY TO THE LESION, THE COIL WAS REPEATEDLY PUSHED AND PULLED. AFTER THE COIL MANAGED TO REACH THE LESION, THE IMPLANT WAS ATTEMPTED TO BE DETACHED WITH A DETACHMENT CONTROLLER. HOWEVER, THE DETACHMENT CONTROLLER DID NOT RESPOND AND FAILED TO DETACH THE IMPLANT. THE COIL WAS THEN REMOVED FROM THE PATIENT USING A SNARE. A SNARE WAS USED FOR REMOVAL AT THE PHYSICIAN¿S DISCRETION. UPON INSPECTION, IT WAS FOUND THAT THE IMPLANT HAD BEEN STRETCHED. A COMPETITOR¿S COIL WAS THEN USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TYPE OF SURGERY: ANEURYSM EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497872 AZUR SOFT3D DETACHABLE 10 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-HS00310 0001103715 04987892128349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DETACHMENT CONTROLLER V-GRIP.