BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 15351415 · Received September 2, 2022

    Report

    Report Number
    2032493-2022-00330
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 18, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00810170012488
    PMA / PMN Number
    K130577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN SELECTED AN AZUR 5MM X 10CM PERIPHERAL HELICAL COIL SYSTEM IN A FISTULOGRAM CASE WHEN REPORTEDLY THE COIL IMPLANT WAS FOUND MISSING IN THE FIRST PACKAGE OPENED. ANOTHER COIL WAS USED TO COMPLETE THE CASE. PROCEDURE OUTCOME WAS SUCCESSFUL AND PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446735 AZUR CX 35 DETACHABLE VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC. 45-250510 200127544 00810170012488

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown