BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16943784 · Received May 17, 2023

    Report

    Report Number
    2029046-2023-01048
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    April 18, 2023
    Report Date
    July 10, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 22-JUN-2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING A "SMARTABLATE GEN. KIT (JAPAN)" AND "RF NEEDLE" WERE USED DURING THE CASE. AS SUCH, THESE ITEMS HAVE BEEN ADDED TO FIELD D10. CONCOMITANT MED PRODUCTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 23-MAY-2023, ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT WERE RECEIVED. IT WAS REPORTED THIS ADVERSE EVENT DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. INTERVENTION PROVIDED INCLUDED PERICARDIAL DRAINAGE. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS ¿IMPROVED¿. ABLATION HAD ALREADY BEEN DONE PRIOR TO NOTING THE CARDIAC TAMPONADE AS THE EVENT OCCURRED DURING THE ABLATION PHASE. AN IRRIGATED CATHETER WAS USED IN THE EVENT WITH THE FLOW SETTINGS, BELOW 30W: 8ML/MIN, ABOVE 31W: 15ML/MIN.. FORCE VISUALIZATION FEATURES USED INCLUDED DASHBOARD; VECTOR AND VISITAG. COLOR OPTIONS WERE USED PROSPECTIVELY INCLUDED TAG INDEX. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT. REGARDING TO THE CARDIAC TAMPONADE, EFFUSION WAS FOUND BY ECHOCATH VISUALIZATION. THE BLOOD PRESSURE WAS DECREASED TO 60¿S. THE PATIENT WAS UNDER SEDATION AND THE CONSCIOUSNESS WAS FADING. WHEN THE SEDATION WAS LIFTED, THE PATIENT RESPONDED. THE NEXT WEEK, THE PATIENT'S CONDITION AND HOSPITALIZATION WERE CHECKED AND FOUND NO FURTHER ISSUES. THE PATIENT WAS TRANSFERRED FROM THE ICU TO THE GENERAL WARD WITHOUT ANY PROBLEMS AND HAS BEEN DISCHARGED NOW. THE HOSPITALIZATION WAS EXTENDED, WHICH WAS FOR 2 DAYS LONGER THAN EXPECTED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND THE DEVICE WAS RECOGNIZED CORRECTLY; HOWEVER, HI FORCE APPEARED DUE TO AN INTERNAL PRINTED CIRCUIT BOARD (PCB) ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. A FORCE ISSUE WAS IDENTIFIED AND CONFIRMED DURING THE ANALYSIS IN THE LAB. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT WHEN THE CATHETER WAS REMOVED FROM THE LEFT ATRIUM AND REINSERTED, IT ENTERED THE SPACE BETWEEN THE RIGHT ATRIUM AND AORTA THE PENTARAY NAV AND ABLATION CATHETER ENTERED THAT AREA SEVERAL TIMES DURING THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: INCOMPATIBLE COMPONENT/ ACCESSORY (C0402) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: CIRCUIT BOARD (G02005) WERE SELECTED AS RELATED TO THE ISSUE OF FORCE ISSUE. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED ADVERSE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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. 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 UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT BLOOD PRESSURE WAS DECREASED, WHICH WAS CONFIRMED BY ECHOCARDIOGRAPHY, AND A PERICARDIAL EFFUSION WAS OBSERVED. TIMING WAS AFTER PULMONARY VEIN ISOLATION (PVI), SUPERIOR VENA VAVA ISOLATION (SVCI) AND NON-PV ABLATION, THE LAST INDUCTION WAS ATTEMPTED. ABLATION WAS PERFORMED BEFORE THE CARDIAC TAMPONADE WAS IDENTIFIED. DRAINAGE WAS DONE AND THE PATIENT¿S BLOOD PRESSURE WAS STABLE AFTER DRAINAGE. STEAM POP WAS NOT CONFIRMED. IRRIGATION CATHETER¿S FLOW RATE SETTING WAS -30W8ML 31W~15ML. DOCTOR'S JUDGMENT ON HEALTH HAZARD WAS THAT IT WAS SERIOUS. DECISION BY THE PHYSICIAN IN CHARGE OF THE HEALTH HAZARD AND ITS INVOLVEMENT WITH THE PRODUCT (CAUSALLY RELATED TO THE PRODUCT) WAS YES. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE PRODUCT WAS THAT WHEN THE CATHETER WAS REMOVED FROM THE LEFT ATRIUM AND REINSERTED, IT ENTERED THE SPACE BETWEEN THE RIGHT ATRIUM AND AORTA THE PENTARAY NAV AND ABLATION CATHETER ENTERED THAT AREA SEVERAL TIMES DURING THE PROCEDURE. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO AND DURING USE OF THE PRODUCT. CONTACT FORCE (CF) MONITORING METHODS INCLUDED DASHBOARD, VECTOR, VISITAG WITH VISITAG COLORING SETTINGS FOR TAG INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830015 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30985803L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Life Threatening| H| R 8.5F SHEATH WITH CURVE VIZ SMC| CARTO 3 SYSTEM| PENTARAY NAV ECO 7FR, D, 2-6-2| RF NEEDLE| SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO GE 8F CATHETER