BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUNAV DX ULTRASOUND CATHETER

    MDR report key: 4451228 · Received January 16, 2015

    Report

    Report Number
    MW5040372
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 16, 2015
    Manufacturer
    STERILMED
    Product Code
    OWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE LEAD EXTRACTION PROCEDURE, THE ACUSON CATHETER ACUNAV DX ULTRASOUND 8FR ISSUED A CATHETER ERROR MESSAGE "EXCEED THERMAL LIMIT" - THIS CATHETER IS A REPROCESSED DEVICE FOR SINGLE USE PROCESSED BY STERILMED, INC. CATHETER NEEDED TO BE REPLACED TO CONTINUE PROCEDURE. FOR THE EP PROCEDURE OF PACEMAKER LEAD EXTRACTION / REIMPLANTATION OF PACEMAKER LEADS, THE PT WAS INTUBATED AND UNDER THE CARE OF ANESTHESIA FOR GENERAL ANESTHESIA, HAD AN ARTERIAL LINE FOR HEMODYNAMIC MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40323 ACUNAV DX ULTRASOUND CATHETER ULTRASOUND CATHETER 8FR OWQ STERILMED 10135936 182

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other