BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS DS

    MDR report key: 24395526 · Received February 19, 2026

    Report

    Report Number
    2029046-2026-00566
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    December 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: SAHIN AT, OZYESIL B, KAN H, KESKIN O, SERTDEMIR AL, GUL EE. HIGH-DENSITY ELECTROANATOMIC MAPPING-GUIDED ABLATION IN AVNRT: THE ROLE OF SLOW PATHWAY LATE ACTIVATION MAPPING TECHNIQUE. J INTERV CARD ELECTROPHYSIOL. 2025 DEC 9. DOI: 10.1007/S10840-025-02170-0. EPUB AHEAD OF PRINT. PMID: 41361158. 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. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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. 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 AND THE FOLLOWING CITATION WAS REVIEWED: SAHIN AT, OZYESIL B, KAN H, KESKIN O, SERTDEMIR AL, GUL EE. HIGH-DENSITY ELECTROANATOMIC MAPPING-GUIDED ABLATION IN AVNRT: THE ROLE OF SLOW PATHWAY LATE ACTIVATION MAPPING TECHNIQUE. J INTERV CARD ELECTROPHYSIOL. 2025 DEC 9. DOI: 10.1007/S10840-025-02170-0. EPUB AHEAD OF PRINT. PMID: 41361158. BACKGROUND AND PURPOSE: SLOW PATHWAY LATE ACTIVATION MAPPING (SLAM) WITH HIGH-DENSITY MAPPING CATHETERS IS A NOVEL ELECTROANATOMICAL TECHNIQUE DESIGNED TO IDENTIFY THE SLOW PATHWAY REGION IN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT). ITS COMPARATIVE EFFICACY AND SAFETY IN ADULTS REMAIN UNDEREXPLORED. THIS STUDY AIMS TO EVALUATE THE EFFICACY AND SAFETY OF SLAM-GUIDED ABLATION IN PATIENTS WITH TYPICAL AVNRT, COMPARED WITH CONVENTIONAL FLUOROSCOPY-BASED SLOW PATHWAY ABLATION. METHODS: THIS SINGLE-CENTER RETROSPECTIVE STUDY INCLUDED 91 PATIENTS WITH TYPICAL AVNRT WHO UNDERWENT CATHETER ABLATION. PATIENTS WERE ASSIGNED TO EITHER SLAM-GUIDED FLUOROLESS ABLATION (N = 41) OR CONVENTIONAL FLUOROSCOPY-GUIDED ABLATION (N = 50). PROCEDURAL CHARACTERISTICS, ACUTE SUCCESS, COMPLICATION RATES, AND FOLLOW-UP OUTCOMES WERE ANALYZED. CONCLUSION: SLAM-GUIDED FLUOROLESS ABLATION IS A SAFE AND EFFECTIVE ALTERNATIVE TO CONVENTIONAL FLUOROSCOPY-GUIDED AVNRT ABLATION. IT ENABLES HIGH-RESOLUTION, PHYSIOLOGICALLY GUIDED TARGETING OF THE SLOW PATHWAY WHILE SIGNIFICANTLY MINIMIZING RADIATION EXPOSURE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 7-FR RADIOFREQUENCY ABLATION CATHETER (CELCIUS D CURVE, BIOSENSE WEBSTER). OTHER BWI DEVICE(S): THREE DIMENSIONAL ELECTROANATOMICAL MAPPING SYSTEM: CARTO 3; HIGH-DENSITY MAPPING CATHETER: PENTARAY. OTHER NON-BWI DEVICE(S): THREE DIMENSIONAL ELECTROANATOMICAL MAPPING SYSTEM: ENSITE PRECISION; HIGH-DENSITY MAPPING CATHETER: HD GRID. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_CELSIUS DS DEVICES: QTY 1: 1 PATIENT IN THE CONVENTIONAL GROUP EXPERIENCED COMPLETE AV BLOCK REQUIRING IMPLANTATION OF A LEFT BUNDLE BRANCH AREA PACING (LBBAP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453543 CELSIUS DS CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTO 3 SYSTEM.| ENSITE PRECISION CARDIAC MAPPING SYSTEM.| HD GRID MAPPING CATHETER, SENSOR ENABLED.| UNK_PENTARAY.