BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER

    MDR report key: 24716724 · Received March 30, 2026

    Report

    Report Number
    2029046-2026-01012
    Event Type
    Injury
    Date Received
    March 30, 2026
    Report Date
    March 27, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: UÇAR M, SASMAZ MI. RADIATION EXPOSURE AND FLUOROSCOPY TIME IN AVNRT ABLATION: ROLE OF 3D ELECTROANATOMICAL MAPPING. BMC CARDIOVASC DISORD. 2026 JAN 3;26(1):101. DOI: 10.1186/S12872-025-05482-1. PMID: 41484950; PMCID: PMC12866499. 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 ARTICLE HAS BEEN REVIEWED: UÇAR M, SASMAZ MI. RADIATION EXPOSURE AND FLUOROSCOPY TIME IN AVNRT ABLATION: ROLE OF 3D ELECTROANATOMICAL MAPPING. BMC CARDIOVASC DISORD. 2026 JAN 3;26(1):101. DOI: 10.1186/S12872-025-05482-1. PMID: 41484950; PMCID: PMC12866499. BACKGROUND: ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) IS THE MOST FREQUENT REGULAR SUPRAVENTRICULAR TACHYCARDIA IN ADULTS. CATHETER ABLATION OF THE SLOW PATHWAY IS CONSIDERED FIRST-LINE THERAPY, OFFERING HIGH SUCCESS WITH LOW COMPLICATION RISK. CONVENTIONAL FLUOROSCOPY-GUIDED ABLATION, HOWEVER, EXPOSES BOTH PATIENTS AND OPERATORS TO IONIZING RADIATION. THREE-DIMENSIONAL (3D) ELECTROANATOMICAL MAPPING SYSTEMS HAVE EMERGED AS A PROMISING ALTERNATIVE TO REDUCE RADIATION WHILE MAINTAINING EFFICACY. OBJECTIVES: THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE IMPACT OF THREE-DIMENSIONAL ELECTROANATOMICAL MAP PING ON RADIATION EXPOSURE PARAMETERS, INCLUDING FLUO ROSCOPY TIME AND DAP, IN PATIENTS UNDERGOING AVNRT ABLATION. METHODS: WE RETROSPECTIVELY REVIEWED 170 PATIENTS WHO UNDERWENT AVNRT ABLATION BETWEEN JUNE 2023 AND AUGUST 2025. A TOTAL OF 112 PATIENTS WERE TREATED USING CONVENTIONAL FLUOROSCOPY GUIDANCE, AND 58 PATIENTS UNDERWENT 3D MAPPING-GUIDED ABLATION. RADIATION EXPOSURE, FLUOROSCOPY TIME, PROCEDURAL OUTCOMES, AND COMPLICATIONS WERE COMPARED BETWEEN GROUPS. CONCLUSIONS: THREE-DIMENSIONAL MAPPING SIGNIFICANTLY REDUCES RADIATION EXPOSURE WITHOUT COMPROMISING SAFETY OR EFFICACY IN AVNRT ABLATION. ADOPTION OF THIS APPROACH MAY ENHANCE PATIENT AND OPERATOR SAFETY IN ROUTINE PRACTICE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTAR® DS BI-DIRECTIONAL CATHE TER (BIOSENSE WEBSTER INC.), EZ STEER THERMOCOOL BI-DIRECTIONAL CATHETER (BIO SENSE WEBSTER INC.). OTHER BWI PRODUCTS: CARTO¿ 3 SYSTEM (BIOSENSE WEBSTER INC., MA, USA), UNIDIRECTIONAL WEBSTER¿ CORONARY SINUS CATHETER (BIOSENSE WEBSTER INC., MA, USA). NON-BWI DEVICES: NONE - 4 CASES OF VASCULAR ACCESS SITE BLEEDING (MINOR COMPLICATION) WILL NOT BE CAPTURED SINCE THE SHEATH DEVICES MENTIONED WERE NOT FROM THE BWI DEVICES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_NAVISTAR DS QTY 1: 1 PATIENT IN THE 3D MAPPING GROUP DEVELOPED TRANSIENT ATRIOVENTRICULAR BLOCK (AV) REQUIRING TEMPORARY PACING, WHICH RESOLVED SPONTANEOUSLY WITHIN 24 H. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_C3 EZ STEER THERMOCOOL NAV QTY 1: 1 PATIENT IN THE CONVENTIONAL GROUP HAD PROCEDURAL FAILURE. QTY 2: 2 PATIENTS IN THE CONVENTIONAL GROUP HAD DEVELOPED PERMANENT ATRIOVENTRICULAR BLOCK REQUIRING PACEMAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774318 EZ STEER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L