BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16480711 · Received March 3, 2023

    Report

    Report Number
    2029046-2023-00465
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    December 2, 2022
    Report Date
    March 3, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: ZHANG X, LI W, LIN A, ZOU F, MARAZZATO J, VARRIAS D, NAGRAJ S, WANG YC, SEO J, DELLA ROCCA DG, LEVINE E, SANTANGELI P, LAKKIREDDY D, NATALE A, DI BIASE L. OUTCOMES OF CATHETER ABLATION OF ATRIAL TACHYARRHYTHMIA GUIDED EXCLUSIVELY BY ACTIVATION MAPPING. J INTERV CARD ELECTROPHYSIOL. 2022 DEC 2. DOI: 10.1007/S10840-022-01435-2. EPUB AHEAD OF PRINT. PMID: 36456653. 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 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. 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: ZHANG X, LI W, LIN A, ZOU F, MARAZZATO J, VARRIAS D, NAGRAJ S, WANG YC, SEO J, DELLA ROCCA DG, LEVINE E, SANTANGELI P, LAKKIREDDY D, NATALE A, DI BIASE L. OUTCOMES OF CATHETER ABLATION OF ATRIAL TACHYARRHYTHMIA GUIDED EXCLUSIVELY BY ACTIVATION MAPPING. J INTERV CARD ELECTROPHYSIOL. 2022 DEC 2. DOI: 10.1007/S10840-022-01435-2. EPUB AHEAD OF PRINT. PMID: 36456653. OBJECTIVE AND METHODS: INTRODUCTION: COMPLEX ATRIAL TACHYARRHYTHMIAS (CATS) ARE COMMONLY OBSERVED IN PATIENTS WITH PRIOR CATHETER ABLATION OR CARDIAC SURGERY. THESE ARRHYTHMIAS ARE CHALLENGING TO MAP AND ABLATE. HISTORICALLY, ENTRAINMENT MAPPING WAS UTILIZED TO CHARACTERIZE CAT. WITH THE ADVENT OF HIGH-DEFINITION MAPPING (HDM), FULL VISUALIZATION OF THE CAT CIRCUIT IS POSSIBLE WHICH MAY OBVIATE THE NEED FOR ENTRAINMENT MAPPING. METHODS: WE SOUGHT TO INVESTIGATE THE OUTCOMES OF CATHETER ABLATION OF CAT GUIDED ONLY BY HDM. CONSECUTIVE PATIENTS WHO UNDERWENT CAT ABLATION FROM 2017 TO 2021 WERE INCLUDED IN OUR STUDY (EXCLUDING RIGHT ATRIAL TACHYARRHYTHMIAS). PATIENTS WERE SORTED BY THE TYPE OF MAPPING PERFORMED. GROUP I CONSISTED OF PATIENTS WHERE HDM ALONE WAS UTILIZED WITH NO ATTEMPT OF ENTRAINMENT. GROUP II CONSISTED OF PATIENTS WHERE BOTH ENTRAINMENT AND HDM WERE UTILIZED. RESULTS: A TOTAL OF 67 PATIENTS WERE INCLUDED IN OUR STUDY, WITH 40 PATIENTS IN HDM GROUP (I) AND 27 PATIENTS IN ENTRAINMENT GROUP (II). NO STATISTICALLY SIGNIFICANT DIFFERENCE REGARDING 1-YEAR FREEDOM FROM ATRIAL ARRHYTHMIAS WAS FOUND BETWEEN THE TWO GROUPS (80% VS 77.8%, P = 0.819). FOUR CATS WERE TERMINATED BY ENTRAINMENT DURING PROCEDURE VERSUS NONE IN THE HDM-ONLY GROUP (P = 0.011). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMART-TOUCH STSF OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3D, CARTO CONFIDENSE MODULE, CARTO PRIME, 10F INTRACARDIAC ECHOCARDIOGRAPHY CATHETER (ACUNAV), STEERABLE 7 FRENCH DECAPOLAR DIAGNOSTIC CATHETER (DECANAV,F CURVE 2-8-2 MM SPACING), FRENCH DUO-DECAPOLAR FIXED DIAGNOSTIC CATHETER (DUO-DECAPOLAR NON NAV, LARGE CURVE 270 2 MM SPACING), AND MULTI-ELECTRODE MAPPING CATHETER (LASSO NAV 2515 OR PENTARAY F CURVE SPACING 2-6-2 MM). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND INTERVENTIONS: 1 POSTOPERATIVE UTI- NO TREATMENT SPECIFIED AND 1 POSTOPERATIVE EXACERBATION OF HEART FAILURE- NO TREATMENT SPECIFIED. THE AUTHORS NOTE THE HEART FAILURE WAS A PREEXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023455 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO CONFIDENSE MODULE| CARTO PRIME| DECANAV,F CURVE 2-8-2 MM SPACING| LASSO NAV 2515 OR PENTARAY F CURVE| NON NAV, LARGE CURVE 270 2 MM SPACING| UNK_ACUNAV| UNK_CARTO 3