BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER

    MDR report key: 4585017 · Received February 11, 2015

    Report

    Report Number
    3027815-2014-00002
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    September 23, 2014
    Report Date
    December 30, 2014
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CF-D7-AAA-NSDA IS A DIAGNOSTIC CATHETER AND IS NOT AN ABLATION CATHETER. IT IS PASSIVE IN NATURE AND DOES NOT PROVIDE THERAPY. CATHETER DOES NOT PROVIDE ABLATION THERAPY AND THERE FOR IF ABLATION THERAPY CAUSED THE SUDDEN DECREASE IN BLOOD PRESSURE THE ACTIVE CATHETER (THE BIOSENSE WEBSTER THERMOCOOL CATHETER) WOULD BE THE CAUSE. SINCE THERE WAS NO REPORT OF FAILURE OF THE TZ MEDICAL CATHETER IT IS EXTREMELY UNLIKELY THAT IT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DURING CARDIAC ABLATION, SUDDEN DECREASE IN BLOOD PRESSURE AND HEART MOTION COMPARED TO BASELINE. PERICARDIAL EFFUSION CONFIRMED AND RESOLVED WITH SUBSEQUENT PERICARDIOCENTESIS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: CARDIAC ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101604 CATHETER DRF TZ MEDICAL, INC. 0216108

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other