BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19048171 · Received April 4, 2024

    Report

    Report Number
    2029046-2024-01137
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    February 5, 2020
    Report Date
    April 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEDN AM, ELDAMATY A, ELHALAG M, ELSHERIF R, ALAASAR H. SEGMENTAL VERSUS CIRCUMFERENTIAL ABLATION OF PULMONARY VEINS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN-ACCESS MACED J MED SCI. 2020 FEB 05; 8(B):85-98. HTTPS://DOI.ORG/10.3889/OAMJMS.2020.3854. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT 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. MANUFACTURER'S REF # (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEDN AM, ELDAMATY A, ELHALAG M, ELSHERIF R, ALAASAR H. SEGMENTAL VERSUS CIRCUMFERENTIAL ABLATION OF PULMONARY VEINS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN-ACCESS MACED J MED SCI. 2020 FEB 05; 8(B):85-98. HTTPS://DOI.ORG/10.3889/OAMJMS.2020.3854. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: PULMONARY VEIN ISOLATION (PVI) IS THE CORNERSTONE OF CATHETER ABLATION TECHNIQUES FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION (PAF), WITH SIGNIFICANTLY IMPROVED EFFICACY COMPARED TO ANTIARRHYTHMIC DRUGS AS SHOWN IN CABANA TRIAL. HOWEVER, THE QUESTION ARISES IN WHICH PAF PATIENTS WHETHER THE PROCEDURE CAN BE LIMITED TO PVS ONLY SHOWING POTENTIALS (SEGMENTAL), OR IT IS REALLY NECESSARY TO ISOLATE ALL PV (CIRCUMFERENTIAL). EVEN THOUGH SUCCESS RATES FOR CIRCUMFERENTIAL PV ABLATION (CPVA) HAVE BEEN REPORTED TO BE HIGHER (UP TO 90%), THAN SEGMENTAL PV ABLATION, MOST CPVA PROCEDURES PREVIOUSLY REPORTED INCLUDED LEFT ATRIAL LINEAR ABLATION, ADDITIONAL ABLATION LESIONS OR LINES CONNECTING THE MITRAL VALVE TO THE POSTERIOR PVS OR ALONG THE ROOF OF THE LEFT ATRIUM WHICH MADE BIAS TO THESE STUDIES. AIM: THUS, AUTHORS INITIATED THIS RANDOMIZED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF CPVA VERSUS SPVI IN SUBJECTS UNDERGOING ABLATION OF PAF. METHODS: STUDY INCLUDED 31 CONSECUTIVE PATIENTS WHO UNDERWENT THEIR FIRST RADIOFREQUENCY ABLATION FOR PAF BETWEEN MARCH 2015 AND MARCH 2017. PATIENTS WERE RANDOMIZED FOR CIRCUMFERENTIAL OR SEGMENTAL ABLATION ON THE DAY OF THE PROCEDURE. WE HAD TWO GROUPS, CIRCUMFERENTIAL (17 PATIENTS) AND SEGMENTAL GROUP (14 PATIENTS). RESULTS: THERE WAS NO DIFFERENCE BETWEEN TWO GROUPS ON OUR PRIMARY ENDPOINT, THE RECURRENCE, WHICH WAS 2 OUT OF 14 PATIENTS (14.3%) IN THE SEGMENTAL ABLATION GROUP, COMPARED TO 3 OUT OF 17 PATIENTS (17.6%) WHO WERE CIRCUMFERENTIAL ABLATED. THIS DIFFERENCE IS STATISTICALLY INSIGNIFICANT (P = 1). FOR OTHER ENDPOINTS, THERE WAS ALSO NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN CIRCUMFERENTIAL AND SEGMENTAL REGARDING FLUOROSCOPY TIME, 53.47 ± 8.7 MIN VERSUS 54.93 ± 15.02 MIN, P = 0.738, PROCEDURE TIME, 184.18 ±19.28 MIN VERSUS 191.43 ± 20 MIN P = 0.315, AND EVEN FOR RADIO FREQUENCY TIME WHICH WAS LOWER IN SEGMENTAL GROUP BUT DID NOT DIFFER STATISTICALLY, 35.71 ± 5.73 MIN VERSUS 34.79 ± 5.29, MIN P = 0.649. CONCLUSION: THE PREVIOUS STUDIES SHOWED THE SUPERIORITY OF CIRCUMFERENTIAL PVI ON SEGMENTAL STRATEGY REGARDING EFFECTIVENESS, BUT IN THOSE STUDIES, LINEAR ABLATIONS WERE ADDED TO CIRCUMFERENTIAL STRATEGY AND DONE IN CASES OF PERSISTENT AND PAF. IN OUR RANDOMIZED STUDY, WE COMPARED BETWEEN TWO METHODS IN CASES OF PAF, WHICH SHOWED THAT SEGMENTAL ABLATION IS NOT INFERIOR TO CIRCUMFERENTIAL ABLATION OF PVI. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH ABLATION CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO3 MAPPING SYSTEM, LASSO MAPPING CATHETER. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NAV X MAPPING SYSTEM (ST. JUDE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER: QTY 1 TAMPONADE PERICARDITIS TREATED WITH PERICARDIOCENTESIS (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATION). QTY 3 POST ABLATION ATRIAL FLUTTER/ATRIAL TACHYCARDIA (ARRHYTHMIA)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267467 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other NAV X MAPPING SYSTEM (ST. JUDE)| UNK_CARTO 3| UNK_LASSO