BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 18170145 · Received November 20, 2023

    Report

    Report Number
    3011610434-2023-00012
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 26, 2023
    Report Date
    December 19, 2023
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    PNE
    UDI-DI
    10841898120275
    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 ON 26-OCT-2023 OF A REPROCESSED AGILIS NXT STEERABLE INTRODUCER FROM KAISER SANTA CLARA MEDICAL CENTER REPORTED TO HAVE VALVE LEAKAGE. NO INJURIES WERE REPORTED. INNOVATIVE HEALTH MADE FOLLOW-UP ATTEMPTS TO OBTAIN THE SUBJECT DEVICE ON 6-NOV-2023 AND 13-NOV-2023 WITH NO RESPONSE. BASED ON THE INFORMATION AVAILABLE AND NOT BEING ABLE TO COMPLETE FURTHER INVESTIGATION ON THE SUBJECT DEVICE, INNOVATIVE HEALTH CANNOT CONFIRM THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED AGILIS INTRODUCER.

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE THAT THE ORIGINAL SUBMISSION CONTAINED AN ERRONEOUS SELECTION ON THE "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" FIELD. NO PATIENT INJURIES WERE REPORTED ASSOCIATED WITH THIS EVENT AND NO APPARENT HARM OCCURRED IN RELATION TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE DEVICE WAS REPORTED TO HAVE VALVE LEAKAGE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796193 N/A STEERABLE INTRODUCER PNE INNOVATIVE HEALTH, LLC. 408310 10841898120275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other