BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4281713 · Received November 26, 2014

    Report

    Report Number
    9673241-2014-00520
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER APPROVED UNDER P030031/S025. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE DEVICE WAS DISPOSED AND NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # (B)(4). PRODUCT: STOCKERT 70 RF GENERATOR, US CATALOG # S7001, SERIAL # UNKNOWN. PRODUCT: COOLFLOW® IRRIGATION PUMP, US CATALOG # CFP002, SERIAL # UNKNOWN. PRODUCT: STERILMED SOUNDSTAR CATHETER (DISTRIBUTED), US CATALOG # UNKNOWN, LOT # UNKNOWN. PRODUCT: SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER, US CATALOG # SNDSTR10, LOT # UNKNOWN. PRODUCT: LASSO NAV ECO CATHETER, US CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING PROCEDURE, A PERFORATION OF THE LEFT ATRIUM WAS NOTICED AS THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY ICE AND PERICARDIOCENTESIS WAS PERFORMED. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME BWI FOLLOWED-UP WITH THE PHYSICIAN. A TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE EVENT OCCURRED DURING ABLATION PHASE. THE PATIENT DID RECEIVED ANTICOAGULATION AND BELIEVED TO BE MAINTAINED IN AN ACT RANGE OF 300 ¿ 350 S. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. HOWEVER, STATED THAT BWI ABLATION CATHETER DID NOT CAUSED THIS EVENT. SETTINGS DURING THE EVENT INCLUDE: GENERATOR UNDER POWER CONTROL MODE USING THERMOCOOL SF WITH ALTERNATING POWER OF 30 W AND FLOW SETTING OF 8 TO 15 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767466 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER SIMILAR DEVICE BNI35DDCT, PMA # P030031/S025 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-00 UNKNOWN_TCOOL SF C3

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R