BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER ¿ THERMOCOOL ® NAV BI-DIRECTIONAL CATHETER.

    MDR report key: 2443049 · Received February 8, 2012

    Report

    Report Number
    2029046-2012-00012
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    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 PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. CONCOMITANT PRODUCTS (NON BWI DEVICES): SAC CATHETER - (B)(4) LIFE LINE, CATALOG AND LOT #: UNKNOWN; 5F SHORT SHEATH (MAP CATHETER) /(B)(4) LIFE LINE, CATALOG AND LOT #: UNKNOWN; 8F SL0 (LIBERO/ (B)(4) LIFE LINE) CATALOG AND LOT #: UNKNOWN; LAMP90 (LASSO) CATALOG AND LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAF (PAROXYSMAL A-FIB) PROCEDURE, RA WAS IMAGED AND TRANSSEPTAL PUNCTURE WAS CONDUCTED AS USUAL AFTER THE CATHETERS WERE PLACED. ABLATION WAS DONE FOR PVI, AROUND THE SVC AND IN THE CTI. WHILE LINE OF BLOCK WAS MADE IN THE CTI (IN THE RA) AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE BEGAN TO DECREASE SO THE PROCEDURE WAS STOPPED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. AFTER THE FLUID WAS DRAINED AND MEDICATION WAS ADMINISTRATED, THE BLOOD PRESSURE AND THE PATIENT'S CONDITION BECAME STABILIZED. AT THE TIME THE EVENT WAS REPORTED, THE PATIENT WAS SENT TO THE CCU (CRITICAL CARE UNIT). ACCORDING TO THE PHYSICIAN, THE IMPEDANCE OF THE EZ STEER CATHETER WAS NOT CHANGED DRASTICALLY DURING ABLATION AND THERE WAS NO ISSUE FELT DURING MANIPULATION. IT WAS NOT DETERMINED AT WHAT POINT THE CARDIAC TAMPONADE OCCURRED.

    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 (IRWINDALE) D-1292-01-S UNKNOWN_D-1292-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R