BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR SOFT3D DETACHABLE 10

    MDR report key: 20467632 · Received October 16, 2024

    Report

    Report Number
    2032493-2024-00761
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 5, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892128349
    PMA / PMN Number
    K122543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT STRETCHED AND ENTANGLED; HOWEVER, THE IMPLANT COIL WAS FOUND TO STILL BE ATTACHED TO THE PUSHER UPON RECEIPT. THE INVESTIGATION OF THE RETURNED DEVICE DID NOT FIND ANY DAMAGE OR OTHER ANOMALY THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PREMATURE DETACHMENT ISSUE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE STRETCHED IMPLANT, BUT THE STRETCHED CONDITION IS CONSISTENT WITH THE DEVICE EXPERIENCING EXCESS TENSION.

    Additional Manufacturer Narrative · 0

    AT THE TIME THIS COMPLAINT WAS RECEIVED, THIS PRODUCT WAS AN EXPORTED DEVICE THAT WAS NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S. THE COMPLAINT IS BEING REPORTED NOW AS BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA. THIS DEVICE IS SIMILAR TO THE V-TRAK HYDRO SOFT 3D, K161367. 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 RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MANIPULATION OF THE COIL THROUGH A MICROCATHETER, THE COIL DID NOT COME OUT OF THE MICROCATHETER. THE COIL WAS RETRIEVED, AND THE IMPLANT WAS FOUND TO BE STRETCHED AND EARLY DETACHED. THE COIL WAS REPLACED WITH ANOTHER COIL FROM A DIFFERENT LOT TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TEN OTHER COILS WERE SUCCESSFULLY USED IN THIS PROCEDURE. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034699 AZUR SOFT3D DETACHABLE 10 PERIPHERAL KRD MICROVENTION, INC. MV-HS00310 0000526079 04987892128349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown