BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17667193 · Received August 31, 2023

    Report

    Report Number
    2029046-2023-01974
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. MANUFACTURER'S REFERENCE NUMBER: (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. THE PATIENT EXPERIENCED A HEART BLOCK AV. IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED LAST WEEK DURING A PREMATURE VENTRICULAR CONTRACTIONS (PVC) PROCEDURE. THEY STATED THAT AFTER MAPPING THE PVC, THE PHYSICIAN BEGAN TO ABLATE THE LOCATION OF THE PVC. THEY STATED THAT THE PVC WENT AWAY, AND THE STAFF PREPARED THE PATIENT FOR AN AFIB PROCEDURE. THE PATIENT WAS INTUBATED, AND PREPARATIONS WERE BEING MADE FOR THE AFIB PROCEDURE. THE CALLER NOTED THAT THE PVC RE-APPEARED, AND THE PHYSICIAN DECIDED TO APPLY MORE ABLATION THERAPY. THE CALLER NOTED THAT THE LOCATION OF THE PVC WAS ANTERIOR SEPTAL, JUST BELOW THE TRICUSPID VALVE. THE PHYSICIAN APPLIED MORE ABLATION THERAPY AND THE PATIENT'S HEART RATE DECREASED. THE CALLER NOTED THAT THE PATIENT STILL HAD A VENTRICULAR INTRINSIC HEART RATE BUT IT WAS VERY SLOW. THE PHYSICIAN THEN WENT TRANSEPTAL AND PERFORMED THE AFIB PROCEDURE. AFTER THE AFIB PORTION OF THE PROCEDURE WAS COMPLETED, THE PHYSICIAN IMPLANTED A PERMANENT PACER MAKER DEVICE IN THE PATIENT. NO FURTHER INTERVENTION WAS MENTIONED. THE CALLER NOTED THAT THE PHYSICIAN BELIEVES THE PVC MAP SHIFTED. NO CATHETERS WERE AVAILABLE FOR RETURN. LOT NUMBER FOR THE STSF CATHETER WAS UNKNOWN BY THE CALLER. MAX WATTAGE USED: 40 WATTS. OTHER BIOSENSE WEBSTER INC. (BWI) PRODUCT: PATCHES, SOUNDSTAR CATHETER, AND BWI CS. THE ADVERSE EVENT WAS DISCOVERED POST ABLATION BELOW THE TRICUSPID VALVE. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS MAP SHIFT. OUTCOME OF THE ADVERSE EVENT WAS HEART BLOCK, PERMANENT PACEMAKER IMPLANTED. PATIENT HAD AN OVERNIGHT STAY FOR OBSERVATION. TRANSSEPTAL PUNCTURE WAS PERFORMED POST ADVERSE EVENT. NO EVIDENCE OF STEAM POP. AN IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS HIGH FLOW RATE. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE AND ¿NO LEARN NEW MESSAGE¿. DASHBOARD , VECTOR, VISITAGS WERE USED. VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WAS 4 SECS, 2 MM AND FOT 3 GRAMS AT 25%. ADDITIONAL FILTER USED WITH THE VISITAG WAS SURPOINT RUNNING IN BACKGROUND. COLOR OPTIONS USED PROSPECTIVELY WAS MANUAL ABLATION POINT. A BWI FIELD SERVICE ENGINEER (FSE) WAS REQUESTED TO FOLLOW UP WITH THE CARTO 3 SYSTEM. CARTO 3 SYSTEM SOFTWARE VERSION: 7.5.1.327 GENERATOR INFORMATION WAS A STOCKERT SMART ABLATE G4C-2501. NO ERRORS ON THE SYSTEM. HIS LOCATION MOVED. THE ISSUE WAS SEEN DURING ABLATING. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS A FEW MILLIMETER CHANGE. THE PATIENT WAS INTUBATED BY ANESTHESIA AND THEN THE MAP SHIFT WAS NOTICED ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023. THE FSE SPOKE TO THE BWI REPRESENTATIVE, AND HE ADVISED THE PATIENT HAD MOVED WHICH CAUSED THE MAP SHIFT. HE ADVISED THE SYSTEM WAS FUNCTIONING NORMALLY. THEY DO NOT NEED THE SYSTEM TESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190295 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention BWI CS CATHETER| BWI PATCHES| CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| UNK_SOUNDSTAR