BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 21653301 · Received March 20, 2025

    Report

    Report Number
    3011610434-2025-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898131349
    PMA / PMN Number
    K210655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON (B)(6) 2025 OF A REPROCESSED EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER REPORTED TO BE "SEPARATED". NO INJURIES OR OTHER CLINICAL SIGNS/SYMPTOMS WERE REPORTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON (B)(6) 2025. THE DEVICE WAS VISUALLY INSPECTED AND THE TIP WAS CONFIRMED TO BE SEPARATED FROM THE DEVICE. THE TIP WAS NOT RETURNED ALONG WITH THE DEVICE FOR INVESTIGATION. DEFORMATION OF THE DEVICE SHAFT AND TRANSDUCER WAS ALSO NOTED. THE INNER CONNECTOR WIRES WERE FOUND TO BE COMPLETELY CUT NEAR THE DEVICE TRANSDUCER. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FACILITY RELATED TO THE USAGE OF THIS DEVICE AND NO INFORMATION WAS PROVIDED TO INNOVATIVE HEALTH.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE DEVICE WAS RETURNED WITH A NOTE STATING, "CATHETER SEPARATED". NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373158 N/A INTRAVASCULAR ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. 85900P 10841898131349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown