BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2671151 · Received July 26, 2012

    Report

    Report Number
    9673241-2012-00196
    Event Type
    Injury
    Date Received
    July 26, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 4, 2012
    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

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: LASSO CATHETER (DEVICE WAS DISCARDED BY THE CUSTOMER/ NOT RETURNED FOR INVESTIGATION). MODEL #: D-1220-38-S, LOT #.: 15549563L. CRISTACATH CATHETER (DEVICE WAS DISCARDED BY THE CUSTOMER/ NOT RETURNED FOR INVESTIGATION). MODEL #: D-1276-01-S, LOT #.: 15563494M. LASSO CATHETER (DEVICE WAS DISCARDED BY THE CUSTOMER/ NOT RETURNED FOR INVESTIGATION) MODEL #: D-1220-39-S, LOT #.: 15542462L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PV ISOLATION (BOTH LEFT AND RIGHT) OF AN AFIB PROCEDURE, ABLATION AT THE ROOF LINE WAS DELIVERED. SUBSEQUENTLY, CAVOTRICUSPID ISTHMUS (CTI) BLOCK LINE WHICH WAS ABLATED IN THE PREVIOUS PROCEDURE WAS CHECKED. THEN THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 90'S AND CARDIAC DEPRESSION WAS CONFIRMED UNDER FLUOROSCOPY. CONTINUOUSLY, THE PERICARDIAL EFFUSION WAS CONFIRMED UNDER THE TRANSTHORACIC ECHOCARDIOGRAM. PERICARDIOCENTESIS WAS PERFORMED AND ABOUT 300ML OF BLOOD WAS DRAINED. THE PROCEDURE WAS COMPLETED AFTER RECOVERY OF THE BLOOD PRESSURE WAS STABILIZED. THE PATIENT HAD A CLEAR SENSORIUM AND WAS IN THE HOSPITAL WARD FOR FOLLOW-UP. PHYSICIAN WAS UNCERTAIN OF THE CAUSE OF CARDIAC TAMPONADE, HOWEVER, STATED THAT THE PATIENT MOVED GREATLY DURING THE PROCEDURE.

    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 15563328M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R