BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16464970 · Received March 1, 2023

    Report

    Report Number
    2029046-2023-00436
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    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 (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT BLOOD PRESSURE DECREASED WHILE LEFT ATRIAL POSTERIOR WALL ISOLATION. PERICARDIAL EFFUSION WAS OBSERVED BY SURFACE ECHOGRAPHY. TIMING WHEN COMPLAINTS OCCURRED WAS AT THE TIME OF LEFT ATRIAL POSTERIOR WALL ISOLATION, IN A STAGE THAT THE PROCEDURE WAS ALMOST COMPLETED. PERICARDIAL PUNCTURE DRAINAGE WAS PERFORMED, AND ABOUT 500 ML OF BLOOD WAS SUCKED. BLOOD PRESSURE DID NOT RECOVER TO THE 40 S. THE PATIENT WAS INTUBATED AND PLACED ON A RESPIRATOR. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND INTRA-AORTIC BALLOON PUMP (IABP) WERE INSERTED. A SWAN-GANZ CATHETER WAS INSERTED INTO THE NECK TO CONTROL THE CONDITION. AFTER EXTRACORPOREAL CIRCULATION WAS STARTED, BLOOD PRESSURE BECAME 100 OR HIGHER. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WITH ASSISTED CIRCULATION AND RESPIRATORY SYSTEM. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND WILL BE FOLLOWED UP. ATRIAL SEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. ABLATION WAS PERFORMED BEFORE PERICARDIAL EFFUSION WAS IDENTIFIED. STEAM POP WAS NOT CONFIRMED. IRRIGATION CATHETER¿S FLOW RATE SETTING WAS: PRE 1 SECOND, POST 2 SECOND. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CAUSE MIGHT BE DUE TO THE PROCEDURE OR PATIENT CONDITION. THE PHYSICIAN COMMENTED THAT THE MEAN CONTACT FORCE (CF) WAS CONSISTENTLY AROUND 15 G, BUT CF TEMPORARILY INCREASED TO 80-90 G DURING THE ROOF ABLATION. IN ADDITION, AS CATHETER STABILITY ON ROOF WAS NOT STABLE, THE ABLATION WAS CONDUCTED SEVERAL TIMES. THIS CATHETER OPERATION MIGHT BE THE CAUSE OF CARDIAC TAMPONADE. THE PATIENT HAD DIALYSIS AND HE WAS SUSPECTED DCM (DILATED CARDIOMYOPATHY), AND HIS CONDITION HAD BEEN POOR SINCE BEFORE THE ABLATION, AND THE MYOCARDIUM WAS WEAK. THE PHYSICIAN HAD AN IMPRESSION THAT THE ABLATION PROCEDURE WAS USUAL, AND THE PATIENT MEDICAL BACKGROUND ALSO HAD A GREAT INFLUENCE. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE NEXT DAY AFTER ABLATION, PERICARDIAL EFFUSION FURTHER ACCUMULATED AND WORSENED, BUT AFTER THAT, THE PATIENT WAS RECOVERING, AND PCPS AND IABP WERE REMOVED AND EXTUBATED. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS CARDIAC DRAINAGE WAS PERFORMED, AND HOSPITALIZATION WAS PROLONGED DUE TO THE USE OF ASSISTED CIRCULATION. PREOPERATIVE ECHOCARDIOGRAM SHOWED EJECTION FRACTION (EF) 20%, MODERATE-SEVERE MR. A SMARTABLATE GENERATOR WAS USED AND THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP FLOW SETTING WAS NORMALLY CONTROLLED BY THE GENERATOR. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE . VISUALIZATION FEATURES USED WERE REAL TIME GRAPH; DASHBOARD; VECTOR; VISITAG. VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WERE ABLATION INDEX AND FORCE OVER TIME (FOT). LOCATION STABILITY: 1.5MM, MINIMUM TIME: 5SEC, FOT: 50% 6, TAG SIZE: 2MM. ADDITIONAL FILTER USED WITH THE VISITAG WAS COLOR OPTIONS USED PROSPECTIVELY WAS TAG INDEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826268 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 30939964L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention| L| H 7FR DECAN,11P,F,2.4MMLE,282MM,| CARTO 3 SYSTEM| PENTARAY NAV ECO 7FR, D, 2-6-2| SMARTABLATE GENERATOR KIT-WW| SOUNDSTAR ECO SMS 8F CATHETER| SWAN-GANZ CATHETER| UNKNOWN PUMP| UNKNOWN RF NEEDLE