BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR 18 DETACHABLE HYDRO

    MDR report key: 16833149 · Received April 28, 2023

    Report

    Report Number
    2032493-2023-00026
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 23, 2023
    Report Date
    April 17, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00810170017858
    PMA / PMN Number
    K162524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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 MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION FOR A GI BLEED, THE SECOND COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE COIL DEPLOYED IN THE CORRECT SITE AND STAYED IN PLACE. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046883 AZUR 18 DETACHABLE HYDRO NEUROVASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC. 45-480204-L 2106085KB 00810170017858

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other