BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW BALLOON WEDGE CATHETER (X2)

    MDR report key: 3070325 · Received March 17, 2013

    Report

    Report Number
    3070325
    Event Type
    Malfunction
    Date Received
    March 17, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 11, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE BALLOON WEDGE PRESSURE CATHETER. NOTED TO BE DEFECTIVE BY PHYSICIAN WHEN PERFORMING HEART CATH ON THIS PATIENT. WEDGE CATHETER WAS REMOVED FROM PATIENT'S BODY WITHOUT HARM TO THE PATIENT. A SECOND WEDGE FROM THE SAME LOT NUMBER WAS THEN USED AND WAS ALSO FOUND TO BE DEFECTIVE. MD REQUESTED THIS REPORT BE FILED FOLLOWING HOSPITAL'S PROTOCOL.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
    111793 ARROW BALLOON WEDGE CATHETER (X2) CATHETER, FLOW DIRECTED DYG TELEFLEX MEDICAL N/A MF2090477

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR