BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 24783639 · Received April 3, 2026

    Report

    Report Number
    2032493-2026-00223
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    04987892128455
    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 PORTION OF THE DEVICE NOT IMPLANTED WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED: THE COIL WAS USED AS THE FIRST COIL TO EMBOLIZE AN INFERIOR PANCREATICODUODENAL ARTERY (IPDA) ANEURYSM USING AN ABILITER MICROCATHETER (HI-LEX). AFTER THE COIL WAS REPEATEDLY PULLED FROM AND PUSHED INTO THE ANEURYSM, THE COIL WAS CAREFULLY POSITIONED IN THE ANEURYSM. THE IMPLANT WAS ATTEMPTED TO BE DETACHED, BUT THE IMPLANT WAS NOT DETACHED. DURING AN ATTEMPT TO REMOVE THE COIL FOR REPLACEMENT, THE IMPLANT WAS UNINTENTIONALLY SEPARATED FROM THE PUSHER. THE IMPLANT PORTION WAS PUSHED INTO THE ANEURYSM AND WAS IMPLANTED USING WATER PRESSURE. A FRAGMENT OF THE COIL CONCERNED WAS DETACHED IN THE CATHETER. IT WAS ATTEMPTED TO BE PUSHED INTO THE ANEURYSM WITH WATER PRESSURE, BUT IT IS BELIEVED TO HAVE REMAINED IN THE CATHETER AND REMOVED ENCLOSED WITHIN THE CATHETER WHEN THE CATHETER WAS REMOVED. IT WAS UNKNOWN WHICH PART OF THE COIL THAT APPEARED TO BE A FRAGMENT BELONGED TO. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER TO CONTINUE THE PROCEDURE. ONE COIL WAS THEN IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO OTHER PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565757 AZUR SOFT3D DETACHABLE 10 DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICROVENTION, INC. MV-HS00619 0000913708 04987892128455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABILITER MICROCATHETER (HI-LEX) NO DETAILS