BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR-35 DETACHABLE HYDRO

    MDR report key: 18432729 · Received January 2, 2024

    Report

    Report Number
    2032493-2024-00026
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 2, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00810170015007
    PMA / PMN Number
    K122316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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 COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, DURING COIL ADVANCEMENT HALFWAY OUT OF THE CATHETER TIP, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE DEVICE WAS REPORTED TO BE INCOMPATIBLE WITH THE CATHETER AS RESISTANCE WAS REPORTED. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628274 AZUR-35 DETACHABLE HYDRO PERIPHERAL KRD MICROVENTION, INC. 45-451230 0000096278 00810170015007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other