BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 16211584 · Received January 19, 2023

    Report

    Report Number
    2032493-2023-00529
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 19, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    PMA / PMN Number
    K151358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 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 FISTULOGRAM PROCEDURE, THE EMBOLIZATION COIL FLIPPED ALONG WITH THE CATHETER SUBSEQUENTLY PREMATURELY DETACHING THE COIL. AN AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE COIL HOWEVER, IT TRAVELED TO THE HEART. IT WAS DECIDED TO LEAVE THE COIL AND MONITOR. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION INDICATED THAT NO FURTHER TREATMENT WAS PLANNED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369267 AZUR CX 35 DETACHABLE PERIPHERAL KRD MICROVENTION, INC. 45-750407 2010305J2

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention