BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16463313 · Received March 1, 2023

    Report

    Report Number
    2029046-2023-00429
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    June 5, 2022
    Report Date
    March 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009163
    PMA / PMN Number
    P030031/S053
    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:LI DL, EL-HARASIS M, MONTGOMERY JA, RICHARDSON TD, KANAGASUNDRAM A, ESTRADA JC, LEAN M, SHOEMAKER MB, SAAVEDRA PJ, TOUCHTON S JR, PATEL B, HERRMANN T, JOHN RM, MICHAUD GF. DURABLE PULMONARY VEIN ISOLATION WITH DIFFUSE POSTERIOR LEFT ATRIAL ABLATION USING LOW-FLOW, MEDIAN POWER, SHORT-DURATION STRATEGY. J CARDIOVASC ELECTROPHYSIOL. 2022 AUG;33(8):1655-1664. DOI: 10.1111/JCE.15550. EPUB 2022 JUN 5. PMID: 35598280. 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:LI DL, EL-HARASIS M, MONTGOMERY JA, RICHARDSON TD, KANAGASUNDRAM A, ESTRADA JC, LEAN M, SHOEMAKER MB, SAAVEDRA PJ, TOUCHTON S JR, PATEL B, HERRMANN T, JOHN RM, MICHAUD GF. DURABLE PULMONARY VEIN ISOLATION WITH DIFFUSE POSTERIOR LEFT ATRIAL ABLATION USING LOW-FLOW, MEDIAN POWER, SHORT-DURATION STRATEGY. J CARDIOVASC ELECTROPHYSIOL. 2022 AUG;33(8):1655-1664. DOI: 10.1111/JCE.15550. EPUB 2022 JUN 5. PMID: 35598280. ABSTRACT: INTRODUCTION: TO TARGET POSTERIOR WALL ISOLATION (PWI) IN ATRIAL FIBRILLATION (AF) ABLATION, DIFFUSE ABLATION THEORETICALLY CONFERS A LOWER RISK OF CONDUCTION RECOVERY COMPARED TO BOX SET. WE SOUGHT TO ASSESS THE SAFETY AND EFFICACY OF DIFFUSE PWI WITH LOW-FLOW, MEDIUM-POWER, AND SHORT-DURATION (LF-MPSD) ABLATION, AND EVALUATE THE DURABILITY OF PULMONARY VEIN ISOLATION (PVI) AND PWI AMONG PATIENTS UNDERGOING REPEAT ABLATIONS. METHODS: WE RETROSPECTIVELY STUDIED PATIENTS UNDERGOING LF-MPSD ABLATION FOR AF (PVI + DIFFUSE PWI) BETWEEN AUGUST 2017 AND DECEMBER 2019. CLINICAL CHARACTERISTICS WERE COLLECTED. KAPLAN-MEIER SURVIVAL ANALYSIS WAS PERFORMED TO STUDY AF/ATRIAL FLUTTER (AFL) RECURRENCE. ABLATION DATA WERE ANALYZED IN PATIENTS WHO UNDERWENT A REPEAT AF/AFL ABLATION. RESULTS: OF THE 463 PATIENTS UNDERGOING LF-MPSD AF ABLATION (PVI ALONE, OR PVI + DIFFUSE PWI), 137 PATIENTS HAD PVI + DIFFUSE PWI. ACUTE PWI WITH COMPLETE ELECTROCARDIOGRAM ELIMINATION WAS ACHIEVED IN 134 (97.8%) PATIENTS. AMONG THE 126 PATIENTS WITH CONSISTENT FOLLOW-UP, 38 (30.2%) PATIENTS HAD AF/AFL RECURRENCE DURING A MEDIAN DURATION OF 14 MONTHS. EIGHTEEN PATIENTS UNDERWENT A REPEAT AF/AFL ABLATION AFTER PVI + DIFFUSE PWI, AND 16 (88.9%) PATIENTS HAD DURABLE PVI, IN CONTRAST TO 10 OF 45 (23.9%) PATIENTS WHO HAD REDO ABLATION AFTER LF-MPSD PVI ALONE. SEVEN PATIENTS (38.9%) HAD DURABLE PWI, WHILE 11 PATIENTS HAD PARTIAL ELECTRICAL RECOVERY AT THE POSTERIOR WALL. THE MEDIAN PERCENTAGE OF AREA WITHOUT ELECTRICAL ACTIVITY AT THE POSTERIOR WALL WAS 70.7%. CONDUCTION BLOCK ACROSS THE POSTERIOR WALL WAS MAINTAINED IN 16 (88.9%) PATIENTS. CONCLUSION: THERE WAS A HIGH RATE OF PVI DURABILITY IN PATIENTS UNDERGOING DIFFUSE PWI AND PVI. PARTIAL POSTERIOR WALL ELECTRICAL RECOVERY WAS COMMON BUT CONDUCTION BLOCK ACROSS THE POSTERIOR WALL WAS MAINTAINED IN MOST PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5-MM THERMOCOOL SMART-TOUCH CONTACT FORCE-SENSING ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY:THEROCOOL SMART-TOUCH CATHETER, CARTO, PENTARAY MAPPING CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 PROCEDURE RELATED CARDIAC TAMPONADE REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201705 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC D132701 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO 3 SYSTEM.| PENTARAY MAPPING CATHETER.| THERMOCOOL SMART-TOUCH CATHETER.