BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS THERMOCOOL

    MDR report key: 22920073 · Received August 28, 2025

    Report

    Report Number
    2029046-2025-02916
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LOH P, GROEN MHA, TAHA K, VELTHUIS BK, FIDDER HH, VINK A, WITTKAMPF FHM, DOEVENDANS PAFM, VAN ES R. FEASIBILITY AND SAFETY OF SINGLE-PULSE ABLATION IN 20 PATIENTS WITH ATRIAL FIBRILLATION. HEART RHYTHM. 2025 MAY 28:S1547-5271(25)02514-7. DOI: 10.1016/J.HRTHM.2025.05.054. EPUB AHEAD OF PRINT. PMID: 40446885. 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. NOTE: FOR FIELD D4.UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LOH P, GROEN MHA, TAHA K, VELTHUIS BK, FIDDER HH, VINK A, WITTKAMPF FHM, DOEVENDANS PAFM, VAN ES R. FEASIBILITY AND SAFETY OF SINGLE-PULSE ABLATION IN 20 PATIENTS WITH ATRIAL FIBRILLATION. HEART RHYTHM. 2025 MAY 28:S1547-5271(25)02514-7. DOI: 10.1016/J.HRTHM.2025.05.054. EPUB AHEAD OF PRINT. PMID: 40446885. BACKGROUND: SINGLE-PULSE ABLATION LEADS TO IRREVERSIBLE ELECTROPORATION (IRE) AND HAS BEEN INTRODUCED AS A NONTHERMAL ABLATION TECHNOLOGY FOR PULMONARY VEIN ISOLATION (PVI). FIRST-IN-HUMAN STUDIES DEMONSTRATED THE ACUTE FEASIBILITY AND SAFETY OF IRE PVI. OBJECTIVE: THIS STUDY AIMED TO FURTHER INVESTIGATE THE SAFETY OF SINGLE-PULSE ABLATION FOR PVI. METHODS: TWENTY PATIENTS WITH SYMPTOMATIC ATRIAL FIBRILLATION UNDERWENT SINGLE-PULSE PVI UNDER CONSCIOUS SEDATION. NONARCING, NONBAROTRAUMATIC, 6 MS, 200 J IRE APPLICATIONS WERE DELIVERED VIA A CUSTOM 14-POLAR CIRCULAR IRE ABLATION CATHETER WITH A VARIABLE HOOP DIAMETER (16¿27 MM). ADENOSINE TESTING WAS PERFORMED AFTER A 30-MINUTE WAITING PERIOD. ON DAY 1 AFTER ABLATION, PATIENTS UNDERWENT ESOPHAGOSCOPY AND BRAIN MAGNETIC RESONANCE IMAGING (MRI) (DIFFUSION-WEIGHTED IMAGING/FLUID-ATTENUATED INVERSION RECOVERY). CONCLUSIONS: ACUTE ELECTRICAL PVI COULD BE ACHIEVED SAFELY AND RAPIDLY. ACUTE SILENT CEREBRAL LESIONS WERE DETECTED IN 3 OF 20 PATIENTS (15%) AND MAY BE CAUSED BY ABLATION OR CHANGES OF THERAPEUTIC AND DIAGNOSTIC CATHETERS OVER A SINGLE TRANSSEPTAL ACCESS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: RF CATHETER (BIOSENSE CELSIUS). OTHER BWI PRODUCTS: (LASSO; BIOSENSE WEBSTER, IRVINE, CA). NON-BWI DEVICES: AGILIS NXT 8.5 STEERABLE SHEATH (ABBOTT, ABBOTT PARK, IL) AND (ENSITE VELOCITY; ABBOTT, ABBOTT PARK, IL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT HAD SILENT ISCHEMIA (LESIONS HAD INCREASED TO 3 TO 6 MM). NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837027 CELSIUS THERMOCOOL CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Life Threatening ABBOTT AGILIS NXT 8.5 STEERABLE SHEATH| LASSO