BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX 18D-LONGER

    MDR report key: 20584499 · Received October 31, 2024

    Report

    Report Number
    2032493-2024-00792
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 18, 2024
    Report Date
    October 31, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00816777024398
    PMA / PMN Number
    K123384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE COIL DETACHED WHEN IT WAS PUSHED OUT INTO THE PATIENT FROM THE CATHETER. NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961551 AZUR CX 18D-LONGER DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. 45-780308-L 0000624241 00816777024398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other