BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL FLOW IRRIGATION PUMP

    MDR report key: 1320966 · Received February 20, 2009

    Report

    Report Number
    1721752-2009-00003
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 23, 2009
    Manufacturer
    HEI, INC
    Product Code
    KQT
    PMA / PMN Number
    P990071/S5
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS COMPLAINT IS STILL IN PROGRESS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN AFIB ABLATION ON THE LEFT ATRIUM, THE LEFT PULMONARY VEINS HAD ALMOST BEEN ISOLATED AND THE PHYSICIAN WAS ABLATING IN THE SEPTAL POSTERIOR WALL, WHEN IT WAS NOTICED THAT THE PATIENT'S SYSTOLIC BLOOD PRESSURE DROPPED TO 40. AN ALLEGED PERICARDIAL EFFUSION WAS NOTED WITH THE SEQUOIA INTRACARDIAC IMAGING. A CATHETER WAS PLACED IN THE PERICARDIUM THROUGH THE PATIENT'S ANTERIOR CHEST WALL TO WITHDRAW THE RED COLORED FLUID. THE PHYSICIAN TERMINATED THE PROCEDURE, AND THE PATIENT WAS STABILIZED, AND REMAINED IN THE HOSPITAL. THIS PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL FLOW IRRIGATION PUMP DRF PUMP, CIRCULATING-FLUID, LOCALIZED HEAT KQT HEI, INC M-5491-02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L NAVISTAR THERMOCOOL TC CATHETER| CARTO XP SYSTEM| STOCKERT GENERATOR| SEQUOIA SYSTEM