BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE GUIDEWIRE 1001780-HC

    MDR report key: 22585970 · Received July 23, 2025

    Report

    Report Number
    MW5173194
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN CATH LAB FOR INFERIOR WALL STEMI [ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION] AND HAD 2 STENTS PLACED IN RCA [RIGHT CORONARY ARTERY]. THE IVUS [INTRAVASCULAR ULTRASOUND] WAS USED AFTERWARDS TO ENSURE THE STENTS WERE PROPERLY PLACED AND DEPLOYED IN THE CORONARY ARTERY. WHEN IVUS IMAGING WAS DONE THE CATHETER COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE NON (B)(6) GUIDEWIRE AT THE SAME TIME. THE IVUS CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AS A SINGLE UNIT. IT APPEARS THAT IVUS CATHETER GOT STUCK ON THE WIRE. NO HARM TO PATIENT BUT COULD HAVE POTENTIALLY CAUSED HARD IF A GUIDEWIRE WAS STILL NEEDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591761 HI-TORQUE GUIDEWIRE 1001780-HC WIRE, GUIDE, CATHETER DQX ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown