BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1953233 · Received January 7, 2011

    Report

    Report Number
    9673241-2011-00007
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETERS WERE NOT RETURNED TO BIOSENSE WEBSTER FOR INVESTIGATION. CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: REFSTAR EXTERNAL REF PATCH; CATALOG NO.: XRP6H; LOT NO.: 15157657. COOLFLOW TUBING SET; CATALOG NO.: CFT001; LOT NO.: 582080.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AF ABLATION PROCEDURE, THE CATHETERS WERE PLACED IN CS, HIS AND RV. AS BROCKENBROUGH METHOD REQUIRED TIME AND THE CATHETER (COMPETITOR'S PRODUCT) WAS INSERTED IN CS AGAIN. THEN BLOOD PRESSURE BEGAN TO DECREASE AND IT WAS NOTED THE POSITION OF THE CATHETER WAS NOT NORMAL. DRAINAGE AND OPEN CHEST SURGERY WAS PERFORMED AS MEDICAL INTERVENTION. THE PHYSICIAN STATED THAT THE EVENT COULD BE CARDIAC TAMPONADE CAUSED BY PERFORATION/ RUPTURE OF THE CATHETER (SNAKE, MANUFACTURED BY (B)(4) LIFELINE) PLACED IN CORONARY VEIN. THE BIOSENSE WEBSTER EZ STEER CATHETER WAS USED FOR MAPPING OF RIGHT ATRIUM AND NO POWER WAS DELIVERED WITH THIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15240928M

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R