BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 20085223 · Received August 28, 2024

    Report

    Report Number
    2029046-2024-02861
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    May 29, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HAQ IU, AKHIYAT N, AL-SHAKARCHI N, SIONTIS KC, MULPURU SK, SUGRUE A, GIUDICESSI J, FRIEDMAN PA, ASIRVATHAM SJ, KILLU AM. ATRIAL FIBRILLATION SUBSTRATE AND CATHETER ABLATION OUTCOMES IN MYBPC3- AND MYH7-MEDIATED HYPERTROPHIC CARDIOMYOPATHY. JACC CLIN ELECTROPHYSIOL. 2024 JUL;10(7 PT 1):1380-1391. DOI: 10.1016/J.JACEP.2024.03.026. EPUB 2024 MAY 29. PMID: 38819352. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HAQ IU, AKHIYAT N, AL-SHAKARCHI N, SIONTIS KC, MULPURU SK, SUGRUE A, GIUDICESSI J, FRIEDMAN PA, ASIRVATHAM SJ, KILLU AM. ATRIAL FIBRILLATION SUBSTRATE AND CATHETER ABLATION OUTCOMES IN MYBPC3- AND MYH7-MEDIATED HYPERTROPHIC CARDIOMYOPATHY. JACC CLIN ELECTROPHYSIOL. 2024 JUL;10(7 PT 1):1380-1391. DOI: 10.1016/J.JACEP.2024.03.026. EPUB 2024 MAY 29. PMID: 38819352. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THE STUDY WAS TO CHARACTERIZE THE ATRIAL SUBSTRATE OF PATIENTS WITH MYBPC3-ENCODED MYOSIN-BINDING PROTEIN C3 OR MYH7-ENCODED SARCOMERE-RELATED B-MYOSIN HEAVY CHAIN MEDIATED HYPERTROPHIC CARDIOMYOPATHY (HCM) AND ITS IMPACT ON CATHETER ABLATION OUTCOMES. BETWEEN JANUARY 2014 AND DECEMBER 2022, A TOTAL OF 12 PATIENTS (10 MALE AND 2 FEMALE) WITH A MEAN AGE OF 55.6 YEARS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS; THE MYBPC3 GROUP WITH 6 PATIENTS AND THE MYH7 GROUP WITH 6 PATIENTS AS WELL. ANOTHER GROUP WAS ALSO INTRODUCED AS THE CONTROL GROUP WITH 15 PATIENTS. THESE PATIENTS WERE SUSPECTED OF HAVING HCM AND UNDERWENT AF CATHETER ABLATION USING A HIGH-DENSITY CATHETER (PENTARAY, NAV ECO, BIOSENSE WEBSTER) USING THE CARTO MAPPING SYSTEM (BIOSENSE WEBSTER). ABLATION WAS PERFORMED USING AN EXTERNALLY IRRIGATED FORCE-SENSING ABLATION CATHETER (THERMOCOOL SMARTTOUCH). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THE STUDY: PENTARAY, NAV ECO; CARTO MAPPING SYSTEM; THERMOCOOL SMARTTOUCH. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH THERMOCOOL SMARTTOUCH (QTY.1). 1 PATIENT HAD POSTPROCEDURAL PERICARDITIS WHICH WAS MEDICALLY MANAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128247 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTO MAPPING SYSTEM.| PENTARAY, NAV ECO.| THERMOCOOL SMARTTOUCH.