BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AQUATRACK

    MDR report key: 15576146 · Received October 11, 2022

    Report

    Report Number
    1016427-2022-05426
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    January 1, 1980
    Report Date
    October 10, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AS REPORTED IN AQUATRACK HYDROPHILIC WIRES SURVEY, THE RESPONDENT INDICATED AN INABILITY TO COMPLETE PROCEDURE SUCCESSFULLY STATING: ¿BEND IN WIRE SHAFT¿ ALSO INDICATED ARTERY SPASM STATING: ¿RESOLVED WITH IC NTG¿ ALSO INDICATED VESSEL PERFORATION STATING, ¿WIRE TIP PERFORATION¿ ALSO INDICATED CREATION OF FALSE LUMEN STATING: ¿DUE TO HYDROPHILIC CHARACTER¿ (RESPONDENT 4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888903 UNKNOWN AQUATRACK WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION UNK-AQUATRACK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| L