BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3071572 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00123
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. NO DEFICIENCIES NOTED. THE DEVICE HISTORY RECORD (DHR) 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 CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: UNKNOWN_CARTO3. SOUNDSTAR, MODEL: M-5723-05, LOT: OEM_M-5723-05 ((B)(4)). MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB)-PERSISTENT PROCEDURE, THE CARTO 3 SYSTEM WAS ACTIVATED NORMALLY AND THE PULMONARY VEIN ISOLATION (PVI) OF BOTH SIDES WERE COMPLETED. THE PATIENT'S STATUS WAS STABLE AFTER THE PVI. THEN ABLATION TARGETING THE INFERIOR VENA CAVA-TRICUSPID ANNULUS ( IVCTA ISTHMUS, THE ISTHMUS BETWEEN THE INFERIOR VENA CAVA AND TRICUSPID ANNULUS) WAS CONDUCTED. DURING ADDITIONAL ABLATION AT IVCTA ISTHMUS, THE BLOOD PRESSURE REDUCTION WAS OBSERVED. A TAMPONADE WAS ALSO CONFIRMED BY ULTRASOUND FINDINGS. DRAINAGE WAS PERFORMED IMMEDIATELY, BUT BLOOD AND FLUID COULD NOT BE DRAINED. EVENTUALLY, PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS APPLIED AND THORACOTOMY WAS PERFORMED IN THE OPERATING ROOM. THE PHYSICIAN STATED THAT EFFUSION HAD BEEN CAUSED BY THE ABLATION AT THE IVCTA ISTHMUS, AND THE DIFFICULTY OF DRAINAGE MIGHT HAVE BEEN DUE TO THROMBUS FORMATION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172239 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15783190L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R