BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERMAN WEDGE CATHETER

    MDR report key: 24019193 · Received January 9, 2026

    Report

    Report Number
    MW5181977
    Event Type
    Death
    Date Received
    January 9, 2026
    Date of Event
    October 13, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A BERMAN ANGIOGRAPHIC CATHETER WAS INADVERTENTLY USED INSTEAD OF THE INTENDED BALLOON WEDGE CATHETER, RESULTING IN A RUPTURED PULMONARY ARTERY DURING AN OUTPATIENT PROCEDURE. PATIENT REQUIRED MULTIPLE INTERVENTIONS TO SUSTAIN LIFE & ICU ADMISSION, HOWEVER ULTIMATELY EXPIRED. BOTH CATHETERS HAVE SIMILAR PACKAGING AND APPEARANCE & ARE MANUFACTURED BY SAME COMPANY (ARROW/TELEFLEX). CONCERN FOR RISK OF RECURRENCE AT OTHER INSTITUTIONS DUE TO SIMILARITY IN PACKAGING & DEVICE APPEARANCE. PT CODE: 2152. DEVICE CODES: 4081, 2958, 4001. REF REPORT: MW5181976.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81109 BERMAN WEDGE CATHETER CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) AI-07126-J

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention| H| D