BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTOWIRE

    MDR report key: 16232535 · Received January 24, 2023

    Report

    Report Number
    16232535
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 16, 2023
    Report Date
    January 17, 2023
    Manufacturer
    OPSENS INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING DRUG-ELUTING STENT (DES) PLACEMENT LEFT ANTERIOR DESCENDING ARTERY (LAD), WIRE TIP BROKE OFF FROM THE MAIN WIRE INSIDE THE VESSEL. WAS ENTRAPPED DUE TO SEVERE CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638184 OPTOWIRE WIRE, GUIDE, CATHETER DQX OPSENS INC III OW-2457B

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Female