BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17168339 · Received June 21, 2023

    Report

    Report Number
    2029046-2023-01337
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 9, 2022
    Report Date
    June 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: BAIMBETOV A, BIZHANOV K, YAKUPOVA I, JUKENOVA A, UALIYEVA A, TURSUNKHANOV Z, BIGELDIYEV N. EFFICACY AND SAFETY RESULTS OF DIFFERENT ABLATION TECHNOLOGIES FOR PERSISTENT ATRIAL FIBRILLATION TREATMENT. HEART SURG FORUM. 2022 AUG 21;25(4):E594-E600. DOI: 10.1532/HSF.4853. PMID: 36052903. OBJECTIVE/METHODS/STUDY DATA:THIS STUDY'S PURPOSE IS A COMPARATIVE ASSESSMENT OF THE EFFICACY AND SAFETY OF TWO STRATEGIES FOR CATHETER TREATMENT IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION.THE STUDY IS A PROSPECTIVE, RANDOMIZED, CONTROLLED RESEARCH DESIGNED TO COMPARE THE RESULTS OF MODERN CATHETER TECHNOLOGIES (RADIOFREQUENCY AND CRYOBALLOON ABLATION) IN PATIENTS WITH PERSISTENT AF. THE STUDY INCLUDED 127 PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION DURING THE LAST SIX MONTHS BEFORE INCLUSION IN THE STUDY. THE AVERAGE FOLLOW-UP PERIOD WAS 24 MONTHS.THE PRIMARY EFFICACY ENDPOINT (DEATH, CEREBROVASCULAR EVENT, OR SERIOUS COMPLICATIONS ASSOCIATED WITH TREATMENT) OCCURRED IN 15 PATIENTS IN THE CRYOBALLOON ABLATION GROUP AND 14 PATIENTS IN THE RADIOFREQUENCY ABLATION GROUP.THE KAPLAN-MEIER SURVIVAL ESTIMATES WERE 30% AND 28%, AND THE RISK RATIO 0.96 AND 95% OF THE CONFIDENCE INTERVAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMART TOUCH CATHETER (BIOSENSE WEBSTER INC., CA, US). OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 NAVIGATION SYSTEM (BIOSENSE WEBSTER INC.), (VISITAG, BIOSENSE WEBSTER,INC.). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 28 MM ARCTIC FRONT CRYOABLATION BALLOON CATHETER,LOOP RECORDER REVEAL XT, (MEDTRONIC,USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 4- PHRENIC NERVE PALSY ALL RESOLVED AFTER 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987099 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 Life Threatening 28 MM ARCTIC FRONT CRYOABLATION BALLOON CATHETER.| LOOP RECORDER REVEAL XT.| UNK_CARTO 3.| UNK_VISITAG SURPOINT¿ EPU.