BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW BERMAN ANGIOGRAPHIC BALLOON CATHETER

    MDR report key: 23778922 · Received December 11, 2025

    Report

    Report Number
    MW5180340
    Event Type
    Death
    Date Received
    December 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE (B)(6) REP THAT THE PHYSICIAN PERFORMED AN RHC (RIGHT HEART CATHETERIZATION) VIA THE PATIENT'S RIGHT FEMORAL VEIN. RA, RV (RIGHT VENTRICULAR) AND PA PRESSURES WERE OBTAINED USING A BERMAN ANGIOGRAPHIC BALLOON CATHETER. PHYSICIAN ATTEMPTED USING THE WEDGE ON RIGHT SIDE WHEN PATIENT STARTED COUGHING UP A SMALL AMOUNT OF BLOOD. THE AMOUNT OF HEMOPTYSIS INCREASED AND THE SITUATION ESCALATED. ANESTHESIA AND SURGERY CALLED TO BEDSIDE. CARDIOMEMS PROCEDURE WAS NOT ATTEMPTED DUE TO PATIENT COMPLICATIONS. SENSOR WAS UNOPENED. NO ADDITIONAL IMAGING OR DOCUMENTATION AVAILABLE AT THIS TIME. ONCE IT WAS KNOWN THAT THE CARDIOMEMS PROCEDURE WAS GOING TO BE ABORTED, THE (B)(6) REP WAS ASKED TO LEAVE THE ROOM. PER THE (B)(6) REP, THE CAUSE OF THE HEMOPTYSIS IS UNKNOWN. THE PATIENT EXPIRED. FURTHER INFORMATION IS NOT AVAILABLE DUE TO THE CARDIOMEMS PORTION OF THE PROCEDURE BEING CANCELLED. 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
    2696241 ARROW BERMAN ANGIOGRAPHIC BALLOON CATHETER CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death