BEUDAMED
    FDA Adverse Event Death Summary report: N

    7 FRENCH ARROW EXCHANGE GUIDEWIRE 0.025"

    MDR report key: 24245022 · Received February 2, 2026

    Report

    Report Number
    MW5183175
    Event Type
    Death
    Date Received
    February 2, 2026
    Date of Event
    January 20, 2026
    Report Date
    January 23, 2026
    Manufacturer
    ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOMEMS IMPLANT PROCEDURE WAS ABORTED ON (B)(6) 2026 DUE TO A LEFT PULMONARY ARTERY PERFORATION THAT OCCURRED PRIOR TO THE CARDIOMEMS SYSTEM BEING OPENED/PREPPED. ADDITIONAL INFORMATION WAS PROVIDED ON 21JAN2026. IT WAS REPORTED THAT THE RIGHT INTERNAL JUGULAR WAS ACCESSED, AND A RIGHT HEART CATHETERIZATION WAS PERFORMED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. PULMONARY CAPILLARY WEDGE PRESSURE WAS TAKEN IN THE RIGHT PULMONARY ARTERY. THE SWAN-GANZ CATHETER WAS ADVANCED WITH A 7 FRENCH ARROW EXCHANGE GUIDEWIRE OVER THE LEFT PULMONARY ARTERY ARCH. THE WIRE WAS REMOVED, AND PULMONARY ARTERY PRESSURE WAS TURNED ON. THE PATIENT STARTED COUGHING UP BLOOD AND THE PHYSICIAN NEVER HAD THE OPPORTUNITY TO WEDGE INTO THE LEFT PULMONARY ARTERY OR TAKE A PULMONARY ARTERY ANGIOGRAM. THE PATIENT WAS INTUBATED AND TAKEN TO THE OPERATING ROOM. THE PATIENT LATER PASSED AWAY. 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
    304237 7 FRENCH ARROW EXCHANGE GUIDEWIRE 0.025" WIRE, GUIDE, CATHETER DQX ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death