BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 19425862 · Received May 30, 2024

    Report

    Report Number
    3011610434-2024-00004
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    August 20, 2024
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    PNE
    PMA / PMN Number
    K170311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE THAT THE ORIGINAL SUBMISSION CONTAINED THE INCORRECT REPORTING ESTABLISHMENT NAME IN SECTION E1.

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON 7-MAY-2024 OF A REPORT FROM KAISER PERMANENT LOS ANGELES MEDICAL CENTER OF A REPROCESSED AGILIS NXT STEERABLE INTRODUCER THAT WAS REPORTED TO HAVE A LEAK. NO INJURIES WERE REPORTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON 16-MAY-2024. THE DEVICE MET THE ACCEPTANCE CRITERIA FOR LEAK TESTING UPON INVESTIGATION. THEREFORE, WITH THE INFORMATION AVAILABLE, INNOVATIVE HEALTH CANNOT CONFIRM THE NOTED ISSUE WITH THE REPORTED DEVICE.

    Description of Event or Problem · 0

    THE DEVICE WAS REPORTED TO HAVE A LEAK. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275838 N/A STEERABLE INTRODUCER PNE INNOVATIVE HEALTH, LLC. 408310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown