BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17572738 · Received August 18, 2023

    Report

    Report Number
    2029046-2023-01799
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31066139L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. E1. INITIAL REPORTER PHONE: (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH SICK SINUS SYNDROME UNDERWENT AN ATRIAL TACHYCARDIA (AT)ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING LEFT PULMONARY VEIN (LPV) ISOLATION, WHEN THE BLOCK LINE WAS BEING CREATED FROM LEFT INFERIOR PULMONARY VEIN (LIPV) BOTTOM TO MITRAL VALVE (MV). AROUND THE 5TH CURRENT OF RIGHT PULMONARY VEIN (RPV) ABLATION, VITAL SIGNS SHOCKED WITH NO CARDIAC ARREST, BUT RESPIRATORY ARREST FROM CARDIAC TAMPONADE. CARDIAC DRAINAGE WAS PERFORMED. BLOOD PRESSURE SYS40 AT SHOCK, AFTER CARDIAC TAMPONADE WAS RELEASED, VITALS AND RESPIRATION STABILIZED, AND THE ABLATION WAS INTERRUPTED. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER INC. PRODUCTS IN THE ABLATION PHASE. ATRIAL SEPTAL PUNCTURE WAS PERFORMED WITH RADIOFREQUENCY (RF). ABLATION HAD ALREADY BEEN PERFORMED BEFORE THE CARDIAC TAMPONADE WAS CONFIRMED. STEAM POP WAS NOT CONFIRMED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PATIENT¿S CONDITION. A PACEMAKER HAD BEEN IMPLANTED IN THE PAST AS CARDIAC FUNCTION WAS POOR. CORRECT CATHETER SETTINGS WERE SELECTED ON THE SMARTABLATE GENERATOR AND THE PUMP SWITCHING WAS FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. IRRIGATION CATHETER¿S FLOW RATE SETTING 1: USED DURING PVI, LOW FLOW 2 ML/M~30W 8ML/M, 31W~15ML/M, SETTING 2: USED FOR NON-PVI, LOW FLOW 2 ML/M~30W 12ML/M, 31W~15ML/M. CONTACT FORCE MONITORING INCLUDED REAL TIME GRAPH; DASHBOARD; VECTOR; VISITAG. VISITAG MODULE WAS USED WITH PARAMETERS FOR STABILITY OF RANGE: 2MM, TIME: 3SEC, FORCE OVER TIME (FOT): 3G 25%, TAG SIZE: 2MM. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. COLORING SETTINGS FOR VISITAG INCLUDED TAG INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333342 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31066139L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| L 7FR DEF LASSONAV SH,12P,15MM,D.| BI DIR 7FR DEFL CS CATH, NON-.| CARTO 3 SYSTEM.| SMARTABLATE GEN. KIT (JAPAN).| SOUNDSTAR ECO SMS 8F CATHETER.| UNKNOWN PUMP.| UNKNOWN RF NEEDLE.