BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18924011 · Received March 18, 2024

    Report

    Report Number
    2029046-2024-00880
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    October 23, 2023
    Report Date
    April 15, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF # (B)(4). IT WAS PREVIOUSLY REPORTED ON THE 3500A INITIAL REPORT MWR-15032024-0001594514 AS ¿QTY 2 CEREBRAL INFARCTION (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION)¿. THE CORRECT QUANTITY IS: ¿QTY 1 CEREBRAL INFARCTION (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION)¿.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: AOYAMA D, MIYAZAKI S, AMAYA N, TAMA N, HASEGAWA K, NOMURA R, TSUJI T, NAKANO A, UZUI H, TADA H. TREATMENT WITH CATHETER ABLATION FOR PATIENTS WITH ARRHYTHMIA-INDUCED CARDIOMYOPATHY CAUSED BY ATRIAL FIBRILLATION PROMISES A GOOD PROGNOSIS. HEART VESSELS. 2024 MAR;39(3):240-251. DOI: 10.1007/S00380-023-02329-7. EPUB 2023 OCT 23. PMID: 37872308. 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: AOYAMA D, MIYAZAKI S, AMAYA N, TAMA N, HASEGAWA K, NOMURA R, TSUJI T, NAKANO A, UZUI H, TADA H. TREATMENT WITH CATHETER ABLATION FOR PATIENTS WITH ARRHYTHMIA-INDUCED CARDIOMYOPATHY CAUSED BY ATRIAL FIBRILLATION PROMISES A GOOD PROGNOSIS. HEART VESSELS. 2024 MAR;39(3):240-251. DOI: 10.1007/S00380-023-02329-7. EPUB 2023 OCT 23. PMID: 37872308. OBJECTIVE/METHODS/STUDY DATA: CLINICAL OUTCOMES AFTER CATHETER ABLATION IN PATIENTS WITH REDUCED LEFT VENTRICULAR (LV) EJECTION FRACTION (EF) AND ATRIAL FIBRILLATION (AF) REMAIN UNCLEAR. THIS STUDY AIMED TO EXPLORE THE CLINICAL OUTCOMES OF PATIENTS WITH ARRHYTHMIA-INDUCED CARDIOMYOPATHY (AIC) AND THE INFLUENCE OF PHARMACOLOGICAL TREATMENT ON CLINICAL OUTCOMES IN PATIENTS WITH AIC AFTER THE PROCEDURE. NINETY-SIX PATIENTS WITH AF WITH A REDUCED LVEF (LVEF < 50%, 66.7 ± 10.9 YEARS; 72 MALES) UNDERWENT AF ABLATION. AIC WAS DEFINED AS PATIENTS WHOSE LVEF RECOVERED = 50% AFTER CATHETER ABLATION (N = 67) AND PATIENTS WHOSE LVEF REMAINED REDUCED WERE DEFINED AS NON-AIC (N = 29). DURING A MEDIAN FOLLOW-UP OF 25 (13-40) MONTHS, KAPLAN-MEIER ANALYSIS DEMONSTRATED THAT PATIENTS WITH AIC WERE ASSOCIATED WITH LESS FREQUENT CARDIOVASCULAR DEATH (P = 0.025) AND HOSPITALIZATION FOR WORSENING HEART FAILURE (P < 0.001) THAN THOSE WITHOUT AIC. FREEDOM FROM AF RECURRENCE WAS SIMILAR BETWEEN THE TWO GROUPS (P = 0.47). IN MULTIVARIATE ANALYSIS, THE LV END-DIASTOLIC DIAMETER (P = 0.0002) AND THE CHA2DS2-VASC SCORES (P = 0.0062) WERE INDEPENDENT PREDICTORS OF AIC. AMONG THE 67 PATIENTS WITH AIC, NO SIGNIFICANT DIFFERENCES IN BASELINE CHARACTERISTICS, EXCEPT FOR LV CHAMBER SIZE AND CRYOBALLOON USE, WERE OBSERVED BETWEEN PATIENTS WITH AIC WITH (N = 31) AND WITHOUT RENIN-ANGIOTENSIN SYSTEM (RAS) INHIBITORS (N = 36). IN THE KAPLAN-MEIER ANALYSIS, CARDIOVASCULAR DEATH, HOSPITALIZATION FOR WORSENING HEART FAILURE, AND AF RECURRENCE AFTER CATHETER ABLATION DID NOT DIFFER BETWEEN PATIENTS TREATED WITH AND WITHOUT RAS INHIBITORS (ALL P > 0.05). CATHETER ABLATION IN PATIENTS WITH AIC DUE TO AF IS ASSOCIATED WITH A GOOD POST-PROCEDURAL PROGNOSIS.IRB INFORMATION THE STUDY WAS APPROVED BY THE RESEARCH ETHICS COMMITTEE OF THE UNIVERSITY OF FUKUI (NO. (B)(6)) AND CLINICAL TRIAL REGISTRATION ((B)(6)). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO3 MAPPING SYSTEM NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ARCTIC FRONT CRYOBALLOON (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY 2 TRANSIENT GASTRIC HYPO-MOTILITY (NEUROLOGIC IMPAIRMENT)(MINOR INJURY) QTY 2 CEREBRAL INFARCTION (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185390 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening ARCTIC FRONT CRYOBALLOON (MEDTRONIC).| CARTO3 MAPPING SYSTEM.