BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 13987152 · Received April 2, 2022

    Report

    Report Number
    2029046-2022-00708
    Event Type
    Injury
    Date Received
    April 2, 2022
    Date of Event
    October 21, 2019
    Report Date
    April 1, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: ANDRADE JG, CHAMPAGNE J, DUBUC M, DEYELL MW, VERMA A, MACLE L, LEONG-SIT P, NOVAK P, BADRA-VERDU M, SAPP J, MANGAT I, KHOO C, STEINBERG C, BENNETT MT, TANG ASL, KHAIRY P; CIRCA-DOSE STUDY INVESTIGATORS. CRYOBALLOON OR RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION ASSESSED BY CONTINUOUS MONITORING: A RANDOMIZED CLINICAL TRIAL. CIRCULATION. 2019 NOV 26;140(22):1779-1788. DOI: 10.1161/CIRCULATIONAHA.119.042622. EPUB 2019 OCT 21. PMID: 31630538. 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. 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: ANDRADE JG, CHAMPAGNE J, DUBUC M, DEYELL MW, VERMA A, MACLE L, LEONG-SIT P, NOVAK P, BADRA-VERDU M, SAPP J, MANGAT I, KHOO C, STEINBERG C, BENNETT MT, TANG ASL, KHAIRY P; CIRCA-DOSE STUDY INVESTIGATORS. CRYOBALLOON OR RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION ASSESSED BY CONTINUOUS MONITORING: A RANDOMIZED CLINICAL TRIAL. CIRCULATION. 2019 NOV 26;140(22):1779-1788. DOI: 10.1161/CIRCULATIONAHA.119.042622. EPUB 2019 OCT 21. PMID: 31630538. OBJECTIVE/METHODS/STUDY DATA:ADVANCED GENERATION ABLATION TECHNOLOGIES HAVE BEEN DEVELOPED TO ACHIEVE MORE EFFECTIVE PULMONARY VEIN ISOLATION (PVI) AND MINIMIZE ARRHYTHMIA RECURRENCE AFTER ATRIAL FIBRILLATION (AF) ABLATION.WE RANDOMLY ASSIGNED 346 PATIENTS WITH DRUG-REFRACTORY PAROXYSMAL AF TO CONTACT FORCE¿GUIDED RADIOFREQUENCY ABLATION (CF-RF; N=115), 4-MINUTE CRYOBALLOON ABLATION (CRYO-4; N=115), OR 2-MINUTE CRYOBALLOON ABLATION (CRYO-2; N=116). FOLLOW-UP WAS 12 MONTHS. THE PRIMARY OUTCOME WAS TIME TO FIRST DOCUMENTED RECURRENCE OF SYMPTOMATIC OR ASYMPTOMATIC ATRIAL TACHYARRHYTHMIA (AF, ATRIAL FLUTTER, OR ATRIAL TACHYCARDIA) BETWEEN DAYS 91 AND 365 AFTER ABLATION OR A REPEAT ABLATION PROCEDURE AT ANY TIME. IN THIS MULTICENTER, RANDOMIZED, SINGLE-BLINDED TRIAL, CF-RF AND 2 DIFFERENT REGIMENS OF CRYOBALLOON ABLATION RESULTED IN NO DIFFERENCE IN 1-YEAR EFFICACY, WHICH WAS 53% BY TIME TO FIRST RECURRENCE BUT >98% BURDEN REDUCTION AS ASSESSED BY CONTINUOUS CARDIAC RHYTHM MONITORING. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH OR SMARTTOUCH SURROUND FLOW; BIOSENSE WEBSTER USED IN CF-RF CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3; BIOSENSE WEBSTER, DIAMOND BAR, CA. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CRYOBALLOON ARCTIC FRONT ADVANCE; MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS" THERE WERE A TOTAL OF THREE AE: PERICARDITIS (1), ESOPHAGEAL PERFORATION(1), CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION (1). THE ARTICLE DOES NOT PROVIDE INFORMATION ON THE SPECIFIC BWI CATHETER THAT CAUSED THESE ADVERSE EVENTS SO ONLY ONE CATHETER IS DOCUMENTED. IF FURTHER INFORMATION IS RECEIVED IT WILL REEVALUATED AND ADDRESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013774 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO3, BIOSENSE WEBSTER, DIAMOND BAR, CA| CRYOBALLOON ARCTIC FRONT ADVANCE, MEDTRONIC)