BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17655988 · Received August 30, 2023

    Report

    Report Number
    2029046-2023-01945
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 30, 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
    NL
    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: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JUL;9(7 PT 2):1013-1023. DOI: 10.1016/J.JACEP.2022.12.011. EPUB 2023 JAN 18. PMID: 36752455. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME ARTICLE. 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: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JUL;9(7 PT 2):1013-1023. DOI: 10.1016/J.JACEP.2022.12.011. EPUB 2023 JAN 18. PMID: 36752455. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND ALTHOUGH CATHETER ABLATION (CA) IS SUCCESSFUL FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION (AF), RESULTS ARE LESS SATISFACTORY IN PERSISTENT AF. HYBRID ABLATION (HA) RESULTS IN BETTER OUTCOMES IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION (PERSAF), AS IT COMBINES A THORACOSCOPIC EPICARDIAL AND TRANSVENOUS ENDOCARDIAL APPROACH IN A SINGLE PROCEDURE. OBJECTIVES THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTIVENESS AND SAFETY OF HA WITH CA IN A PROSPECTIVE, SUPERIORITY, UNBLINDED, RANDOMIZED CONTROLLED TRIAL. METHODS FORTY-ONE ABLATION-NAIVE PATIENTS WITH (LONG-STANDING)-PERSAF WERE RANDOMIZED TO HA (N ¼ 19) OR CA (N ¼ 22) AND RECEIVED PULMONARY VEIN ISOLATION, POSTERIOR LEFT ATRIAL WALL ISOLATION AND, IF NEEDED, A CAVOTRICUSPID ISTHMUS ABLATION. THE PRIMARY EFFICACY ENDPOINT WAS FREEDOM FROM ANY ATRIAL TACHYARRHYTHMIA >5 MINUTES OFF ANTIARRHYTHMIC DRUGS AFTER 12 MONTHS. THE PRIMARY AND SECONDARY SAFETY ENDPOINTS INCLUDED MAJOR AND MINOR COMPLICATIONS AND THE TOTAL NUMBER OF SERIOUS ADVERSE EVENTS. RESULTS AFTER 12 MONTHS, THE FREEDOM OF ATRIAL TACHYARRHYTHMIAS OFF ANTIARRHYTHMIC DRUGS WAS HIGHER IN THE HA GROUP COMPARED WITH THE CA GROUP (89% VS 41%, P ¼ 0.002). THERE WAS 1 PERICARDITIS REQUIRING PERICARDIOCENTESIS AND 1 FEMORAL ARTERIOVENOUS-FISTULA IN THE HA GROUP (ASSOCIATED WITH SHEATH THAT IS NOT IDENTIFIED IN THE ARTICLE). IN THE CA ARM, 1 BLEEDING FROM THE FEMORAL ARTERY OCCURRED (ASSOCIATED WITH SHEATH THAT IS NOT IDENTIFIED IN THE ARTICLE). THERE WERE NO DEATHS, STROKES, NEED FOR PACEMAKER IMPLANTATION, OR CONVERSIONS TO STERNOTOMY, AND THE NUMBER OF (SERIOUS) ADVERSE EVENTS WAS COMPARABLE BETWEEN GROUPS (21% VS 14%, P ¼ 0.685). CONCLUSIONS HYBRID AF ABLATION IS AN EFFICACIOUS AND SAFE PROCEDURE AND RESULTS IN BETTER OUTCOMES THAN CATHETER ABLATION FOR THE TREATMENT OF PATIENTS WITH PERSISTENT AF. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY:CARTO WITH VISITAG NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED SMARTTOUCH ABLATION CATHETER: QTY 1 (PERICARDITIS) REQUIRING PERICARDIOCENTESIS (RECOGNIZED PROCEDURAL COMPLICATION). ADDITIONAL INFORMATION WAS RECEIVED ON 22-AUG-2023. AUTHOR PROVIDED FURTHER DETAILS THAT THE PERICARDITIS WAS TAMPONADE THAT REQUIRED REHOSPITALIZATION AND RE-OPERATION WITH SUBXIPHOIDAL DRAINAGE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 UNTIL (B)(6) 2017 AND THEN RE-OPERATION COMMENCED ON (B)(6) 2017. NO FURTHER INFORMATION CAN BE PROVIDED ON PATIENT DEMOGRAPHICS OR SPECIFIC DEVICE IDENTIFICATION. AUTHORS ALSO REPORT THAT ANOTHER ADVERSE EVENT CAN BE POSSIBLY ASSOCIATED WITH A BIOSENSE WEBSTER DEVICE: 1 BLEEDING FROM THE FEMORAL ARTERY IN THE CATHETER ARM ON (B)(6) 2017. INITIAL PROCEDURE TOOK PLACE ON (B)(6) 2017. THIS ADVERSE EVENT IS CLINICALLY ASSOCIATED WITH A UTILIZATION OF A SHEATH DURING FEMORAL VEIN/ARTERY ACCESS. AUTHORS INDICATE DEVICE IDENTITY INFORMATION CANNOT BE PROVIDED. THEREFORE, IT IS ASSUMED THAT A BIOSENSE WEBSTER VIZIGO SHEATH WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679753 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| R CARTO WITH VISITAG| UNK_CARTO VIZIGO SHEATH