BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTÉGÉ¿ GPS¿

    MDR report key: 15401597 · Received September 12, 2022

    Report

    Report Number
    15401597
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 12, 2022
    Manufacturer
    EV3, INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PLACING THE STENT INTO THE LVAD TRACT THE DELIVERY SYSTEM MAKE A CRACKING SOUND. THE STENT WAS UNABLE TO BE DEPLOYED AND REMOVED. NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821287 PROTÉGÉ¿ GPS¿ CATHETER, BILIARY, DIAGNOSTIC FGE EV3, INC SERB65-14-80-120 B273393

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA Male