BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 17132080 · Received June 14, 2023

    Report

    Report Number
    2032493-2023-00795
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 21, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128493
    PMA / PMN Number
    K123384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 IS REPORTED AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS. AT THIS TIME THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES COIL STRETCHING AND PREMATURE COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED FOR EVALUATION: PUSHER. IMPLANT. NON-MICROVENTION MICROCATHETER ITEMS NOT RETURNED FOR EVALUATION: INTRODUCER DISPENSER HOOP SHRINK LOCK. THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND HEATER COIL KINKED WITH THE IMPLANT NOT ATTACHED TO THE PUSHER, BUT NO INDICATIONS OF ACTIVATION WAS OBSERVED ON THE PUSHER HEATER COIL. THE IMPLANT WAS RETURNED SEPARATED FROM THE PUSHER, STRETCHED, TANGLED AND PARTIALLY STUCK INSIDE THE RETURNED MICROCATHETER. DURING THE INVESTIGATION, THE PUSHER'S MONOFILAMENT WAS FOUND BROKEN, INDICATING THAT THE DEVICE EXPERIENCED A TENSILE BREAK. THE RETURNED MICROCATHETER WAS ALSO EVALUATED AND FOUND TO BE IN GOOD CONDITION WITH NO OBSERVABLE DAMAGE/KINKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANEURYSM TREATMENT DURING A PEDIATRIC CASE, THE COIL WAS UNABLE TO BE POSITIONED AND COULD NOT BE WITHDRAWN. THE COIL APPEARED TO BE STRETCHED AND PREMATURELY DETACHED FROM THE DELIVERY PUSHER. THE COIL WAS WITHDRAWN WITH THE MICROCATHETER AND REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408685 AZUR SOFT3D DETACHABLE 10 PERIPHERAL KRD MICROVENTION, INC. MV-HS00728 0000289936 04987892128493

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other