BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 17130763 · Received June 14, 2023

    Report

    Report Number
    2029046-2023-01292
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    January 27, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIN S, LIN W, FANG X, LIAO H, ZHAN X, FU L, JIANG J, YE X, LIU H, CHEN Y, PU S, WU S, DENG H, XUE Y. HIGH-POWER, SHORT-DURATION ABLATION UNDER THE GUIDANCE OF RELATIVELY LOW ABLATION INDEX VALUES FOR PAROXYSMAL ATRIAL FIBRILLATION: LONG-TERM OUTCOMES AND CHARACTERISTICS OF RECURRENT ATRIAL ARRHYTHMIAS. J CLIN MED. 2023 JAN 27;12(3):971. DOI: 10.3390/JCM12030971. PMID: 36769620; PMCID: PMC9917927. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIN S, LIN W, FANG X, LIAO H, ZHAN X, FU L, JIANG J, YE X, LIU H, CHEN Y, PU S, WU S, DENG H, XUE Y. HIGH-POWER, SHORT-DURATION ABLATION UNDER THE GUIDANCE OF RELATIVELY LOW ABLATION INDEX VALUES FOR PAROXYSMAL ATRIAL FIBRILLATION: LONG-TERM OUTCOMES AND CHARACTERISTICS OF RECURRENT ATRIAL ARRHYTHMIAS. J CLIN MED. 2023 JAN 27;12(3):971. DOI: 10.3390/JCM12030971. PMID: 36769620; PMCID: PMC9917927. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE DIFFERENCE IN EFFECTIVENESS AND SAFETY OF HIGH-POWER, SHORT-DURATION (HPSD) RADIOFREQUENCY CATHETER ABLATION (RFA) GUIDED BY RELATIVELY LOW ABLATION INDEX (AI) VALUES AND CONVENTIONAL RFA IN PAROXYSMAL ATRIAL FIBRILLATION (PAF) PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: OPEN-IRRIGATED, 3.5 MM COOLED-TIP CATHETER (THERMOCOOL SMART TOUCH® UNI-DIRECTIONAL CATHETER OR THERMOCOOL SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: (PENTARAY NAV CATHETER OR LASSO; BIOSENSE-WEBSTER INC., DIAMOND BAR, CA, USA) WITH THE GUIDANCE OF THE CARTO THREE-DIMENSIONAL MAPPING SYSTEM (BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA), CARTO SYSTEM. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: A DIAGNOSTIC DECAPOLAR CATHETER (TRIGUY STEERABLE DECAPOLAR MAPPING CATHETER; APT MEDICAL, SHENZHEN, CHINA), ENSITE VELOCITY SYSTEM (ABBOTT, ST. PAUL, MN, USA), A RHYTHMIA SYSTEM (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: FIVE PATIENTS HAD PERICARDIAL EFFUSION, OF WHICH ONE PATIENT HAD A REDUCTION IN PERICARDIAL EFFUSION AFTER CONSERVATIVE TREATMENT, THREE PATIENTS RECEIVED INSERTION OF A PERICARDIAL DRAIN, AND ONE PATIENT REQUIRED SURGICAL TREATMENT. IN THE CONVENTIONAL GROUP, THREE PATIENTS WHO DEVELOPED PERICARDIAL EFFUSION REQUIRED INSERTION OF A PERICARDIAL DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875324 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D133601 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L CARTO THREE-DIMENSIONAL MAPPING SYSTEM| ENSITE VELOCITY SYSTEM (ABBOTT, ST. PAUL, MN, USA| PENTARAY NAV CATHETER OR LASSO, BIOSENSE-WEBSTER| RHYTHMIA SYSTEM (BOSTON SCIENTIFIC, MARLBOROUGH| TRIGUY STEERABLE DECAPOLAR MAPPING CATHETER