BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 12545507 · Received September 29, 2021

    Report

    Report Number
    9681477-2021-00015
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    July 23, 2021
    Report Date
    September 29, 2021
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    UDI-DI
    08714729743040
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PER EMAIL, IT WAS REPORTED THAT: STARTER WIRE LOOKS DEFORMED BEFORE USE. HERE IS SOME ADDITIONAL INFORMATION ON THE GUIDEWIRE. 05AUG2021 JLC: RESPONSE RECEIVED FROM GAYATHRY N VADIVAL ON 02AUG2021 WHAT WAS THE ANATOMY LOCATION THAT THE PHYSICIAN WAS WORKING ON? LEFT MAIN TO LAD . PLEASE PROVIDE LESION DETAILS: % STENOSIS? LEFT MAIN 50%, LAD 70%. CALCIFICATION? (NOT CALCIFIED, MILD, MODERATE, SEVERE). CONCENTRIC CALCIUM IN LEFT MAIN, INTIMAL CALCIFICATION AT LAD. TORTUOSITY? (NOT TORTUOUS, MILD, MODERATE, SEVERE). NOT STATED . WHEN IS THE EXPECTED DATE THIS DEVICE WILL BE RETURNED? BY THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445710 STARTER GUIDEWIRE GUIDEWIRE DQX LAKE REGION MEDICAL LIMITED M001491181 5999717 08714729743040

    Patients

    Seq Age Sex Outcome Treatment
    1