BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15469787 · Received September 23, 2022

    Report

    Report Number
    2029046-2022-02289
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 25, 2022
    Report Date
    September 22, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 74-YEAR-OLD FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE, HEART BLOCK REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. AFTER MAPPING WITH A DECANAV CATHETER AND PERFORMING 2 RADIOFREQUENCY (RF) APPLICATIONS, 26 SECONDS AND 63 SECONDS DURATION, (IN THE INTERSEPTAL PAPILLARY MUSCLE AREA), THE PATIENT SUFFERED A PERICARDIAL EFFUSION. ABOUT TWO MINUTES AFTER THE SECOND ABLATION, THE PATIENT HAD BRADYCARDIA, AND HEART BLOCK WAS NOTED ON THE ELECTROCARDIOGRAM (ECG). PACING WAS INITIATED, AND AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS USED TO IMAGE THE HEART AND A CARDIAC TAMPONADE WAS THEN NOTED. A PERICARDIOCENTESIS WAS PERFORMED, AND AT LEAST 300 ML OF FLUID WAS REMOVED. CARDIOTHORACIC (CT) SURGEON WAS CONSULTED, AND THE PATIENT HAS BEEN TRANSPORTED TO THE OR FOR SURGICAL INTERVENTION. THE PATIENT WAS TACHYCARDIC WITH PERFUSING BLOOD PRESSURE WHEN THEY LEFT THE EP PROCEDURE ROOM. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A PERFORATION. A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED AS A RETROGRADE AORTIC ACCESS WAS USED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. THE IRRIGATED CATHETER WAS USED IN THE EVENT AND THE FLOW SETTING WAS 8/15 ML. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE CARDIAC TAMPONADE WAS CONFIRMED WITH SOUNDSTAR. THE PROCEDURE WAS ABANDONED AND THERE WAS NO EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE. ON FOLLOW UP, THE PATIENT WAS STABLE AND WAS STILL HOSPITALIZED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE PATIENT HAD OPEN HEART SURGERY TO REPAIR LEFT VENTRICLE (LV) PERFORATION. THE GENERATOR USED WAS A SMARTABLATE GENERATOR. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, AND VECTOR. VISITAG WAS NOT USED. THE PRODUCT AND PACKAGING WERE DISPOSED OF BY THE HOSPITAL STAFF. THEREFORE, THE LOT NUMBER IS UNKNOWN AND PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534044 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| L| R 7FR DECAN,11P,D,2.4 MMLE,282 MM,| SMARTABLATE PUMP KIT-US| UNK_CARTO 3| UNK_SOUNDSTAR