BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS

    MDR report key: 8492284 · Received April 8, 2019

    Report

    Report Number
    2134265-2019-03597
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729114567
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COATING ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERY IN THE GROIN. A 018/180 PLATINUM PLUS GUIDEWIRE WAS ADVANCED. HOWEVER, WHEN THEY PUT THE WIRE THROUGH AN INTRODUCER, THE COATING OF THE WIRE STARTED SHREDDING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286351 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39935 0022117737 08714729114567

    Patients

    Seq Age Sex Outcome Treatment
    1