BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX 18D-LONGER

    MDR report key: 20196762 · Received September 11, 2024

    Report

    Report Number
    2032493-2024-00677
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    September 2, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892032851
    PMA / PMN Number
    K123384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AVAILABLE BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, IMPLANT WAS EARLY DETACHED. THE IMPLANT WAS UNINTENTIONALLY DETACHED IN A CARRY LEON UX19 MICROCATHETER (UTM). THE ENTIRE COIL WAS WITHDRAWN AND REMOVED FROM THE PATIENT. THE COIL WAS THEN REPLACED WITH ANOTHER COIL TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473529 AZUR CX 18D-LONGER DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. MV-AX81032CL 0000215889 04987892032851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other