BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS

    MDR report key: 15396648 · Received September 9, 2022

    Report

    Report Number
    2124215-2022-32235
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729114567
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 3 018/180 PLATINUM PLUS GUIDEWIRE WAS CROSSED THE LESION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE TIP WAS PARTIALLY DISLODGED FROM THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138945 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39935 0029086779 08714729114567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown