BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW BALLOON WEDGE PRESSURE CATHETER

    MDR report key: 3146651 · Received June 3, 2013

    Report

    Report Number
    3146651
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    June 1, 2013
    Manufacturer
    TELEFLEX, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO SMOOTHLY ADVANCE WIRE INTO 5FR. BALLOON WEDGE CATHETER, OR CATHETER/WIRE COMBINATION INTO PT'S VESSEL. CATHETER REMOVED AND VISUAL INSPECTION REVEALED SLIGHT TWIST OR KINK APPROX 10CM FROM HUB OF CATHETER. CATHETER USE WAS DISCONTINUED DUE TO PROBABLE MANUFACTURER DEFECT. NO WIRES WOULD PASS THROUGH THE CATHETER. THE DOCTORS ALSO TRIED AN ARGON 0.035 X 150 CM STRAIGHT WIRE, AND 0.025 X 150 CM STRAIGHT WIRE, BOTH OF WHICH ARE NORMALLY ACCEPTED BY THE CATHETER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIAC CATHETERIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242577 ARROW BALLOON WEDGE PRESSURE CATHETER CATHETER, FLOW DIRECTED DYG TELEFLEX, INC. * MF2121688

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO