BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 13178725 · Received January 6, 2022

    Report

    Report Number
    2032493-2022-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892062919
    PMA / PMN Number
    K151358
    Product Problem
    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 THIS 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 IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS 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 IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, AN EMBOLIZATION COIL IMPLANT UNEXPECTEDLY DETACHED IN A CATHETER. THE DELIVERY PUSHER WAS REMOVED FROM THE CATHETER AND THEN A GUIDEWIRE WAS USED TO PUSH THE IMPLANT INTO THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, AN EMBOLIZATION COIL IMPLANT UNEXPECTEDLY DETACHED IN A CATHETER. THE DELIVERY PUSHER WAS REMOVED FROM THE CATHETER AND THEN A GUIDEWIRE WAS USED TO PUSH THE IMPLANT INTO THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805756 AZUR CX 35 DETACHABLE VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC. MV-AX50824CD 2007225K9 04987892062919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown