BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 17164046 · Received June 20, 2023

    Report

    Report Number
    2029046-2023-01319
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    December 1, 2022
    Report Date
    June 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: SHI WR, WU SH, ZOU GC, XU K, JIANG WF, ZHANG Y, QIN M, LIU X. A NOVEL APPROACH FOR QUANTITATIVE ELECTROGRAM ANALYSIS FOR DRIVER IDENTIFICATION: IMPLICATIONS FOR ABLATION IN PERSISTENT ATRIAL FIBRILLATION. FRONT CARDIOVASC MED. 2022 DEC 1;9:1049854. DOI: 10.3389/FCVM.2022.1049854. PMID: 36531714; PMCID: PMC9751199. 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. 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: SHI WR, WU SH, ZOU GC, XU K, JIANG WF, ZHANG Y, QIN M, LIU X. A NOVEL APPROACH FOR QUANTITATIVE ELECTROGRAM ANALYSIS FOR DRIVER IDENTIFICATION: IMPLICATIONS FOR ABLATION IN PERSISTENT ATRIAL FIBRILLATION. FRONT CARDIOVASC MED. 2022 DEC 1;9:1049854. DOI: 10.3389/FCVM.2022.1049854. PMID: 36531714; PMCID: PMC9751199. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY SOUGHT TO STUDY THE FEASIBILITY, EFFICACY, AND SAFETY OF USING MULTISCALE ENTROPY (MSE) ANALYSIS TO GUIDE CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION (PSAF) AND PREDICT ABLATION OUTCOMES. THIS STUDY PROSPECTIVELY ENROLLED 108 PATIENTS UNDERGOING INITIAL ABLATION FOR PSAF. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH (STSF) CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO, PENTARAY NAV CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SL1-TYPE SWARTZ SHEATHS (ST. JUDE MEDICAL), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: SERIOUS ADVERSE EVENTS INCLUDE ONE PATIENT WITH PERICARDIAL EFFUSION AND ONE WHO SUFFERED FROM A TRANSIENT ISCHAEMIC ATTACK (TIA). THEY WERE MANAGED CONSERVATIVELY WITH NO LONG-TERM SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692710 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO| PENTARAY NAV CATHETER| SL1-TYPE SWARTZ SHEATHS (ST. JUDE MEDICAL)