BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3160606 · Received June 10, 2013

    Report

    Report Number
    9673241-2013-00186
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM U.S. CATALOG #: FG540000 SERIAL #: (B)(4). STOCKERT 70 SYSTEM U.S. CATALOG #: S7001 SERIAL #: (B)(4). COOL FLOW PUMP US CATALOG #: CFP002 SERIAL #: (B)(4). LASSO NAV VARIABLE ECO U.S. CATALOG #: D134301 LOT #: 15829185L. REPROCESSED ACUNAV AND CS CATHETERS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ULTRA SOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE UNIT (ICU). UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. ALSO A DEFLECTION AND IRRIGATION TESTS WERE PERFORMED AND THE CATHETER PASSED ALL TESTS. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ULTRA SOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE UNIT (ICU). MULTIPLE ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WERE PERFORMED WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260232 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-04-S 15415015MA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R