BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 21151795 · Received January 14, 2025

    Report

    Report Number
    2032493-2025-00062
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 14, 2025
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    UDI-DI
    04987892128394
    Adverse Event
    Yes
    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 BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA. THIS DEVICE IS SIMILAR TO V-TRAK HYDRO SOFT 3D, 510K # 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 IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PROCEDURAL OR MEDICAL IMAGING WAS NOT PROVIDED. WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION IS UNABLE TO DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EVENT AS DESCRIBED COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY, THE MICROCATHETER AND GUIDING CATHETER WERE BEING REMOVED FROM THE PATIENT, AND IT WAS DISCOVERED THAT THE STRETCHED COIL EXTENDED APPROXIMATELY 10 CM FROM THE SHEATH INTRODUCER TO THE BODY SURFACE. THE STRETCHED COIL WAS ATTEMPTED TO BE REMOVED WITH A SNARE, BUT THE COIL WAS SEVERED AT THE FILAMENT SECTION AND REMOVAL WAS UNSUCCESSFUL. THE PROCEDURE WAS TERMINATED. THE STRETCHED COIL IS PRESENT FROM THE RIGHT INTERNAL ILIAC ARTERY TO THE INGUINAL LIGAMENT OF THE LEFT COMMON FEMORAL ARTERY AND WILL BE REMOVED DURING A Y-GRAFT REPLACEMENT PROCEDURE TO BE PERFORMED AT A LATER DATE. THE PATIENT CONDITION WAS REPORTED AS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987846 AZUR SOFT3D DETACHABLE 10 DEVICE VASCULAR FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. MV-HS00415 0000706437 04987892128394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention