BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH

    MDR report key: 5357283 · Received January 11, 2016

    Report

    Report Number
    5357283
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    October 4, 2015
    Report Date
    November 5, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MAPPING OF AN ABLATION PROCEDURE, THE CATHETER PLACED IN THE BODY OF THE PATIENT FOR MAPPING WORKED FOR THE FIRST PART OF THE CASE AND JUST STOPPED ABOUT HALF WAY THROUGH. IT WAS STATED BY THE REP THAT THE FIBER OPTICS PROBABLY STOPPED WORKING. A NEW ONE WAS USED WITH A DIFFERENT LOT (# 5192444), IT WORKED THROUGHOUT THE REST OF THE CASE. THERE WAS NO HARM TO THE PATIENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16029 TACTICATH CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL PN-004 065 5135375

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR