BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_CELSIUS THERMOCOOL

    MDR report key: 22918897 · Received August 28, 2025

    Report

    Report Number
    2029046-2025-02912
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    April 6, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: SCIACCA V, FELDT J, ROTTNER L, HEEGER CH, SOHNS C, REISSMANN B, SAGUNER AM, SANTORO F, TILZ RR, MAURER T, RILLIG A, OUYANG F, LINZ D, VERNOOY K, SOMMER P, SULTAN A, WILLEMS S, KUCK KH, METZNER A, FINK T. PERIPROCEDURAL SAFETY OF INTERVENTIONAL ELECTROPHYSIOLOGICAL PROCEDURES IN OCTOGENARIANS AND NONAGENARIANS. J CARDIOVASC ELECTROPHYSIOL. 2025 MAY 26. DOI: 10.1111/JCE.16689. EPUB AHEAD OF PRINT. PMID: 40420477. 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 AND THE FOLLOWING CITATION WAS REVIEWED: SCIACCA V, FELDT J, ROTTNER L, HEEGER CH, SOHNS C, REISSMANN B, SAGUNER AM, SANTORO F, TILZ RR, MAURER T, RILLIG A, OUYANG F, LINZ D, VERNOOY K, SOMMER P, SULTAN A, WILLEMS S, KUCK KH, METZNER A, FINK T. PERIPROCEDURAL SAFETY OF INTERVENTIONAL ELECTROPHYSIOLOGICAL PROCEDURES IN OCTOGENARIANS AND NONAGENARIANS. J CARDIOVASC ELECTROPHYSIOL. 2025 MAY 26. DOI: 10.1111/JCE.16689. EPUB AHEAD OF PRINT. PMID: 40420477. BACKGROUND AND PURPOSE: CATHETER ABLATION IS AN ESTABLISHED TREATMENT FOR CARDIAC ARRHYTHMIA. THERE IS A LACK OF DATA ON INVASIVE ELECTROPHYSIOLOGICAL (EP) PROCEDURES IN AGED PATIENTS. METHODS: CONSECUTIVE PATIENTS = 80 YEARS WHO UNDERWENT CATHETER ABLATION OR LEFT ATRIAL APPENDAGE CLOSURE PROCEDURES BETWEEN JANUARY 2005 AND DECEMBER 2017 IN A HIGH-VOLUME CENTER WERE RETROSPECTIVELY STUDIED AND COMPARED TO A MATCHED CONTROL GROUP OF INDIVIDUALS < 80 YEARS OF AGE. BWI DEVICES THAT WERE USED IN THIS STUDY: 7 F 3.5 MM TIP ABLATION CATHETERS (CELSIUS OR THERMOCOOL, BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA) NON-BWI DEVICES: ENDOCARDIAL DEVICE (WATCHMAN, BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) NOTE: THE VASCULAR COMPLICATION NOTED IN THE ARTICLE WAS NOT IDENTIFIED WHETHER IT IS BWI DEVICE OR NON-BWI DEVICE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_CELSIUS THERMOCOOL (QTY 51) - 17 CASES HAD BLEEDING AT VASCULAR ACCESS SITE, NO INTERVENTION NOTED. - 13 CASES HAD CARDIAC TAMPONADE, NO INTERVENTION NOTED. - 2 CASES HAD PULMONARY EMOBOLISM, NO INTERVENTION NOTED. - 3 CASES HAD STROKE, NO INTERVENTION NOTED. - 2 CASES HAD RESPIRATORY FAILURE WITH NEED FOR INVASIVE VENTILLATION. - 2 CASES UNDER AGED GROUP HAD AV BLOCK WITH SUBSEQUENT PERMANENT PEACEMAKER IMPLANTATION. - 2 CASES HAD PNEUMOTHORAX WITH DRAINAGE. - 2 CASES HAD PHERENIC NERVE PALSY. - 1 CASE HAD GASTROPARESIS. - 7 CASES OF DEATH (2 CARDIAC TAMPONADE, 2 PULMONARY ARTERY EMBOLISM, 2 DECOMPENSATED LEFT HEART FAILURE DURING VT STORY, 1 PNEUMONIA AFTER ASPIRATION DURING THE ABLATION PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247122 UNK_CELSIUS THERMOCOOL CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H ENDOCARDIAL DEVICE (WATCHMAN, BOSTON SCIENTIFIC)