BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 20389643 · Received October 7, 2024

    Report

    Report Number
    2029046-2024-03305
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. E1 INITIAL REPORTER ADDRESS LINE 1: (B)(6). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GUO F, WANG J, WU M, YANG S, HE C, LU M, ZHAO X, JIANG H, LIAO Q, LI S. NOVEL INSIGHT INTO NEUROFILAMENT LIGHT CHAIN AND RHYTHM OUTCOMES AFTER CATHETER ABLATION OF NEW-ONSET ATRIAL FIBRILLATION: A PROSPECTIVE COHORT STUDY. HEART RHYTHM. 2024 AUG 27:S1547-5271(24)03266-1. DOI: 10.1016/J.HRTHM.2024.08.048. EPUB AHEAD OF PRINT. PMID: 39197737. 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 PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GUO F, WANG J, WU M, YANG S, HE C, LU M, ZHAO X, JIANG H, LIAO Q, LI S. NOVEL INSIGHT INTO NEUROFILAMENT LIGHT CHAIN AND RHYTHM OUTCOMES AFTER CATHETER ABLATION OF NEW-ONSET ATRIAL FIBRILLATION: A PROSPECTIVE COHORT STUDY. HEART RHYTHM. 2024 AUG 27:S1547-5271(24)03266-1. DOI: 10.1016/J.HRTHM.2024.08.048. EPUB AHEAD OF PRINT. PMID: 39197737. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ATRIAL FIBRILLATION (AF) IS AN AGE-RELATED DISORDER CLOSELY LINKED TO AUTONOMIC NERVOUS SYSTEM DYSFUNCTION. NEUROFILAMENT LIGHT CHAIN (NFL) PROTEIN IS A BIOMARKER FOR NEURODEGENERATIVE DISEASES. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE PREDICTIVE VALUE OF NFL IN FORECASTING AF RECURRENCE AFTER ABLATION. METHODS: PATIENTS NEWLY DIAGNOSED WITH AF WHO UNDERWENT CATHETER ABLATION WERE INCLUDED. SERUM NFL LEVELS WERE MEASURED USING ENZYME-LINKED IMMUNOSORBENT ASSAY. THE PRIMARY OUTCOME WAS AF RECURRENCE DURING FOLLOW-UP. RESULTS: A TOTAL OF 215 CONSECUTIVE PATIENTS WERE ENROLLED, WITH AVERAGE FOLLOW-UP PERIOD OF 10.69 MONTHS. DURING THIS PERIOD, 29 PATIENTS EXPERIENCED AF RECURRENCE. MULTIVARIATE COX REGRESSION ANALYSIS REVEALED THAT HIGH NFL LEVELS (=300 PG/ML) WERE AN INDEPENDENT PREDICTOR OF RECURRENCE RISK (ADJUSTED HAZARD RATIO [HR] 3.756; 95% CONFIDENCE INTERVAL [CI] 1.392-10.136). THE ASSOCIATIONS BETWEEN NFL LEVELS AND AF RECURRENCE WERE CONSISTENT ACROSS SUBGROUPS DEFINED BY AGE (>65 YEARS), GENDER, HYPERTENSION, AND PAROXYSMAL AF. RESTRICTED CUBIC SPLINE ANALYSIS SHOWED A CONSISTENT LINEAR RELATIONSHIP ACROSS THE ENTIRE RANGE OF NFL LEVELS. FURTHERMORE, INCORPORATING NFL INTO THE CHA2DS2-VASC SCORE MODEL SIGNIFICANTLY IMPROVED THE PREDICTION OF RECURRENT AF RISK, AS DEMONSTRATED BY TIME-DEPENDENT AREA UNDER THE CURVE AND DECISION CURVE ANALYSIS. NOTABLE ENHANCEMENTS WERE ALSO OBSERVED IN TERMS OF NET RECLASSIFICATION IMPROVEMENT (HR 0.464; 95% CI 0.226-0.675; P <.05) AND INTEGRATED DISCRIMINATION IMPROVEMENT (HR 0.087; 95% CI 0.017-0.183; P = .08). CONCLUSION: NFL MAY SERVE AS AN EFFECTIVE BIOMARKER FOR RISK STRATIFICATION AND THERAPEUTIC DECISION-MAKING IN PATIENTS WITH NEW-ONSET AF WHO HAVE UNDERGONE CATHETER ABLATION LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMART TOUCH ABLATION CATHETER CONCOMITANT NON-BIOSENSE WEBSTER DEVICE THAT WAS ALSO USED IN THIS STUDY: 8F SHEATH, SWARTZ LONG SHEATHS (MANUFACTURERS: UNKNOWN) CONCOMITANT BIOSENSE WEBSTER DEVICE THAT WAS ALSO USED IN THIS STUDY: CARTO MAPPING SYSTEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMO-COOL SMARTTOUCH CATHETER (QTY (B)(4). 1 PATIENT HAD ACUTE MYOCARDIAL INFARCTION POST ABLATION. THE TIMING OF THE EVENT AS WELL AS THE TREATMENT PROVIDED WAS NOT MENTIONED IN THE ARTICLE SINCE THIS PATIENT WAS EXCLUDED FROM THE STUDY DUE TO THE OCCURRENCE OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247977 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 8F SHEATH| SWARTZ LONG SHEATHS| UNK_CARTO 3