BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14 CONTROL WIRE

    MDR report key: 15681634 · Received October 27, 2022

    Report

    Report Number
    2124215-2022-42192
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729799221
    PMA / PMN Number
    K112745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE USER FACILITY/MEDWATCH 5112257 THAT GUIDE WIRE COATING ISSUE AND DEVICE ENTRAPMENT OCCURRED. A 300CM V-14 CONTROL WIRE WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS FOUND THAT THE COATING OVER DISTAL PORTION (APPROXIMATELY 7MM) OF THE GUIDEWIRE WAS RETAINED IN CALCIFIED PLAQUE OF THE RIGHT LOWER EXTREMITY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480720 V-14 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 40456 0029445979 08714729799221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other