BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 17515957 · Received August 11, 2023

    Report

    Report Number
    2032493-2023-00897
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 11, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128257
    PMA / PMN Number
    K223050
    Adverse Event
    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 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 COIL UNRAVELING AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING POSITIONING OF AN COIL EMBOLIZATION, THE COIL BECAME UNRAVELED. THE COIL WAS WITHDRAWN SUCCESSFULLY USING AN ENDOVASCULAR SNARE. A NEW COIL WAS USED TO CONTINUE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596713 AZUR SOFT3D DETACHABLE 10 PERIPHERAL KRD MICROVENTION, INC. MV-HS00206 0000177382 04987892128257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention