BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIZIGO

    MDR report key: 24746830 · Received March 31, 2026

    Report

    Report Number
    2029046-2026-01047
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: FU X, GAO J, GUO M, SUN M, ZHANG N, WANG R. THROMBOSIS OCCURRING DURING TRANSSEPTAL PUNCTURE WITH ELECTROCAUTERY: A CASE REPORT. HEART RHYTHM O2. 2025 OCT 14;7(1):183-187. DOI: 10.1016/J.HROO.2025.10.004. PMID: 41695495; PMCID: PMC12902277. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. 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: FU X, GAO J, GUO M, SUN M, ZHANG N, WANG R. THROMBOSIS OCCURRING DURING TRANSSEPTAL PUNCTURE WITH ELECTROCAUTERY: A CASE REPORT. HEART RHYTHM O2. 2025 OCT 14;7(1):183-187. DOI: 10.1016/J.HROO.2025.10.004. PMID: 41695495; PMCID: PMC12902277. BACKGROUND AND PURPOSE: ABSTRACT. ELECTROCAUTERY-ASSISTED TRANSSEPTAL PUNCTURE OFFERS CLINICAL ADVANTAGES BUT IS ASSOCIATED WITH POTENTIAL COMPLICATIONS. HEREIN, WE DESCRIBE A CASE ENCOUNTERED DURING RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION, IN WHICH INTRACARDIAC ECHOCARDIOGRAPHY DETECTED A THROMBUS THAT FORMED AFTER ELECTROCAUTERY AND GUIDEWIRE TRAVERSAL OF THE INTERATRIAL SEPTUM. THE THROMBUS APPEARED AS A HYPERECHOIC, CORD-LIKE STRUCTURE ADHERENT TO THE RIGHT ATRIAL SIDE OF THE INTERATRIAL SEPTUM. PROMPT HEPARIN ADMINISTRATION LED TO THROMBUS RESOLUTION WITHOUT EMBOLIZATION, ENABLING THE PROCEDURE TO CONTINUE SAFELY. THIS CASE UNDERSCORES THE THROMBOTIC RISK OF ELECTROCAUTERY TRANSSEPTAL PUNCTURE AND HIGHLIGHTS THE NEED FOR FURTHER RESEARCH ON OPTIMAL ANTICOAGULATION STRATEGIES. THE LITERATURE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO ASSOCIATED SPECIFIC ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CANNOT BE ASSOCIATED WITH A SPECIFIC DEVICE MANUFACTURER DUE TO INSUFFICIENT INFORMATION: (N=1): 51-YEAR-OLD MALE (85 KG), AFTER THE FOURTH ENERGY DELIVERY THE ICE REVEALED A NEWLY DETECTED CORD-LIKE HYPERECHOIC STRUCTURE MEASURING APPROXIMATELY 1.3 CM IN LENGTH AND 0.3 CM IN WIDTH. IT WAS LOCATED ON THE RIGHT ATRIAL SIDE OF THE INTERATRIAL SEPTUM, ADJACENT TO THE PUNCTURE SITE, AND WAS OBSERVED TO MOVE SYNCHRONOUSLY WITH CARDIAC CONTRACTIONS. ACUTE THROMBOSIS WAS SUSPECTED, AND THE PROCEDURE WAS PROMPTLY TERMINATED. TO MITIGATE THE RISK OF PULMONARY EMBOLISM FROM POTENTIAL THROMBUS DISLODGEMENT, AN INITIAL WEIGHT-BASED HEPARIN BOLUS OF 7000 IU WAS IMMEDIATELY ADMINISTERED. APPROXIMATELY 2 MINUTES LATER, THE THROMBUS WAS OBSERVED TO HAVE DISAPPEARED UNDER ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800822 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

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