BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTRO1PHYSIOLOGY CATHETER

    MDR report key: 15316210 · Received August 29, 2022

    Report

    Report Number
    2029046-2022-02027
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835008357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: TAKAMATSU S, TACHIBANA M, II N, HASUI Y, MATSUMOTO K, BANBA K. PROPER USE OF FENTANYL FACILITATES ANESTHESIA DURING PULMONARY VEIN ISOLATION. HEART VESSELS. 2022 JUN;37(6):1034-1043. DOI: 10.1007/S00380-021-02001-Y. EPUB 2022 JAN 7. PMID: 34993585. 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 CITATION HAS BEEN REVIEWED: TAKAMATSU S, TACHIBANA M, II N, HASUI Y, MATSUMOTO K, BANBA K. PROPER USE OF FENTANYL FACILITATES ANESTHESIA DURING PULMONARY VEIN ISOLATION. HEART VESSELS. 2022 JUN;37(6):1034-1043. DOI: 10.1007/S00380-021-02001-Y. EPUB 2022 JAN 7. PMID: 34993585. OBJECTIVE/METHODS/STUDY DATA: THE AUTHORS AIMED TO CLARIFY THE OPTIMAL FENTANYL DOSAGE AND TIMING OF ADMINISTRATION FOR THE ANESTHETIC MANAGEMENT DURING PVI. A TOTAL OF 364 PATIENTS WITH ATRIAL FIBRILLATION (AF) WHO UNDERWENT PVI AT OUR INSTITUTION BETWEEN JUNE 2017 AND OCTOBER 2020 WERE RECRUITED. ALL PATIENTS WERE ANESTHETIZED WITH PROPOFOL FOR INDUCTION AND MAINTENANCE UNDER CONTROLLED VENTILATION VIA THE SUPRAGLOTTIC AIRWAY WITHOUT NEUROMUSCULAR BLOCKING DRUGS. AMONG THEM, 234 PATIENTS RECEIVED LESS FREQUENT INJECTIONS (GROUP 1) AND 130 RECEIVED A SCHEDULED INJECTION OF 50 MG OF FENTANYL (GROUP 2) IN ADDITION TO PROPOFOL DURING PVI. THE MEAN PATIENT AGE WAS 67.2 YEARS, AND 69% WERE MALE. THE TOTAL PROPOFOL DOSE WAS SIGNIFICANTLY LOWER IN GROUP 2 THAN IN GROUP 1 (17.0¿±¿5.2 MG/KG VS. 19.0¿±¿5.5 MG/KG, P¿<¿0.01). THE LOADING DOSE AND FREQUENCY OF ADDITIONAL PROPOFOL WERE ALSO SIGNIFICANTLY LOWER IN GROUP 2 THAN IN GROUP 1. THE PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN GROUP 2 THAN IN GROUP 1 (119¿±¿36 MIN VS. 132¿±¿31 MIN, P¿<¿0.01).IN GROUPS 1 AND 2, PVI WAS SUCCESSFULLY COMPLETED IN ALL CASES; HOWEVER, SIX OF THE TOTAL PATIENTS EXPERIENCED COMPLICATIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTER THERMOCOOL SMARTTOUCH SF CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO, CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: TEMPERATURE PROBE( FE-PO ET WATCHER, FKD-SP-3, FUKUDA DENSHI). NOTED THAT QTY 1 PATIENT EXPERIENCED A HEMATOMA AT THE PUNCTURE SITE (ANATOMICAL LOCATION SUCH AS ATRIAL SEPTAL OR FEMORAL VEIN IS NOT PROVIDED) AND IS ASSOCIATED WITH A PUNCTURE DEVICE. THE ARTICLE DOES NOT IDENTIFY THE PUNCTURE DEVICE, AND THE MANUFACTURER OF THE PUNCTURE DEVICE IS NOT DISCUSSED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (POSSIBLY ASSOCIATED WITH THE CARDIAC ABLATION CATHETER) : QTY 1 SYMPTOMATIC CEREBRAL INFARCTION - NO SPECIFIC INFORMATION PROVIDED REGARDING INTERVENTIONS AND PATIENT COMPLETELY RECOVERED WITHIN A WEEK AFTER ABLATION. QTY 2 PROLONGED PHRENIC NERVE PARALYSIS - NO SPECIFIC INFORMATION PROVIDED REGARDING INTERVENTIONS AND PATIENTS FULLY RECOVERED WITHIN 3 MONTHS. QTY 2 GASTRIC HYPOMOTILITY - NO SPECIFIC INFORMATION PROVIDED REGARDING INTERVENTIONS AND PATIENTS FULLY RECOVERED WITHIN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273932 NAVI-STAR¿ THERMO-COOL¿ ELECTRO1PHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NI75TCCH 10846835008357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening