BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 16360566 · Received February 13, 2023

    Report

    Report Number
    2029046-2023-00268
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    August 11, 2022
    Report Date
    February 12, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN L, GAO H, LIANG T, ZHAO X. CATHETER ABLATION FOR PATIENTS ON HEMODIALYSIS WITH SYMPTOMATIC ATRIAL FIBRILLATION. ANN PALLIAT MED. 2022 SEP;11(9):2862-2870. DOI: 10.21037/APM-22-410. EPUB 2022 AUG 11. PMID: 35989647. 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 THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN L, GAO H, LIANG T, ZHAO X. CATHETER ABLATION FOR PATIENTS ON HEMODIALYSIS WITH SYMPTOMATIC ATRIAL FIBRILLATION. ANN PALLIAT MED. 2022 SEP;11(9):2862-2870. DOI: 10.21037/APM-22-410. EPUB 2022 AUG 11. PMID: 35989647. OBJECTIVE AND METHODS: BACKGROUND: THERE ARE LIMITED STUDIES ON THE EFFICACY AND SAFETY OF CATHETER ABLATION (CA) FOR PATIENTS WITH ATRIAL FIBRILLATION (AF) WHO RECEIVE INTERMITTENT HEMODIALYSIS (HD). THIS GAP IN THE CONTEMPORARY LITERATURE IS NOTABLE AS PATIENTS WITH AF RECEIVING HD HAS HIGHER INCIDENCE OF AF AND DOES NOT OFTEN TOLERATE MEDICAL MANAGEMENT DUE TO RENAL FAILURE. METHODS: FROM MAR 2015 AND JAN 2018, 25 CONSECUTIVE PATIENTS ON REGULAR HD FROM TWO CARDIAC CENTERS WHO UNDERWENT CA WERE RETROSPECTIVELY ENROLLED. ANOTHER 100 PATIENTS WITHOUT HD OR RENAL IMPAIRMENT, MATCHED BY AGE, SEX, AND AF TYPE, WERE ENROLLED FROM THESE CARDIAC CENTERS AS THE CONTROL GROUP. ALL PATIENTS WERE FOLLOWED UP AT MONTH 3, 6, AND EVERY 6 MONTHS AFTER THE FIRST CAS FOR 4 YEARS, AND 2.5 YEARS AFTER A SECOND CA (IF APPLICABLE), UNLESS ENDPOINTS WERE REACHED. THE PRIMARY ENDPOINT WAS AF RECURRENCE AFTER CA, AND THE SECONDARY ENDPOINTS INCLUDED SYMPTOMATIC AF AND ALL-CAUSE MORTALITY DURING THE FOLLOW-UP PERIOD. RESULTS: AF PATIENTS RECEIVING INTERMITTENT HD HAD A HIGHER PREVALENCE OF HYPERTENSION (P=0.005), AND HEART FAILURE (P=0.041). DURING THE MEAN FOLLOW-UP PERIOD OF 37.6±17.4 MONTHS AFTER THE FIRST CA, 14 OUT OF THE 25 HD PATIENTS (56.0%) REMAINED FREE FROM AF RECURRENCE, COMPARED WITH 77 IN THE CONTROL PATIENTS (77.0%; P=0.021). TWENTY (80.0%) PATIENTS IN THE HD GROUP DID NOT EXPERIENCE SYMPTOMATIC AF. SECOND CAS WERE PERFORMED ON 5 HD PATIENTS AND 11 CONTROL PATIENTS, CONSEQUENTLY 4 OUT OF 5 (80.0%) HD PATIENTS AND 7 OUT OF 11 (63.6%) CONTROL PATIENTS HAD NO AF RECURRENCE (P=0.626) WITHIN 21.1±12.0 MONTHS AFTER THE SECOND CA. TAMPONADE WAS THE ONLY PROCEDURAL COMPLICATION DOCUMENTED IN BOTH GROUPS. ALL-CAUSE MORTALITY WAS HIGHER IN THE HD GROUP (LOG-RANK P=0.004); HOWEVER, THE OBSERVED MORTALITY WAS NOT RELATED TO AF RECURRENCE. CONCLUSIONS: CA IS A POTENTIAL EFFICACIOUS AND SAFE TREATMENT OF AF FOR HD PATIENTS. THE AF RECURRENCE RATE IS HIGHER AFTER A SINGLE ABLATION COMPARED WITH THE GENERAL POPULATION, BUT MULTIPLE ABLATIONS SEEM TO IMPROVE OUTCOMES FOR HD PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 2 CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654317 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO 3 SYSTEM.