BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIZIGO

    MDR report key: 23692387 · Received December 2, 2025

    Report

    Report Number
    2029046-2025-03965
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    March 27, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: BERTE B, VALERIANO C, RISSOTTO S, SIGAL A, KLEMM O, MAHIDA S, DE POTTER T, PÜRERFELLNER H, KOBZA R. PERFORMANCE OF A NEW RESPIRATORY COMPENSATED STABILITY ALGORITHM DURING RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2025 OCT;68(7):1465-1474. DOI: 10.1007/S10840-025-02031-W. EPUB 2025 MAR 27. PMID: 40148702. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BERTE B, VALERIANO C, RISSOTTO S, SIGAL A, KLEMM O, MAHIDA S, DE POTTER T, PÜRERFELLNER H, KOBZA R. PERFORMANCE OF A NEW RESPIRATORY COMPENSATED STABILITY ALGORITHM DURING RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION. J INTERV CARD ELECTROPHYSIOL. 2025 OCT;68(7):1465-1474. DOI: 10.1007/S10840-025-02031-W. EPUB 2025 MAR 27. PMID: 40148702. BACKGROUND: SHORT-DURATION RADIOFREQUENCY ABLATION IS DESIGNED TO ENHANCE EFFICIENCY OF PULMONARY VEIN ISOLATION (PVI). WE INVESTIGATED THE PERFORMANCE OF A NOVEL STABILITY ALGORITHM (STABILITY+). METHODS: IN A PROSPECTIVE, SINGLE-CENTER STUDY, CONSECUTIVE PATIENTS UNDERGOING FIRST-TIME PVI WERE INCLUDED. PATIENTS WERE CATEGORIZED INTO FOUR GROUPS: GROUP 1, HYBRID (ANTERIOR, 50 W, 550 AI; POSTERIOR, 90 W 4 S) USING VIISTAG; GROUP 2, HYBRID USING STABILITY+; GROUP 3, 90 W (ANTERIOR AND POSTERIOR, 90 W 4 S) USING VISITAG; GROUP 4, 90 W USING STABILITY+. CLINICAL, PROCEDURAL AND FOLLOW-UP DATA WERE SYSTEMATICALLY COLLECTED. CONCLUSIONS: IRRESPECTIVE OF THE MODE OF ABLATION, THE NOVEL STABILITY+ALGORITHM CAN BE USED IN PVI ABLATIONS WITHOUT COMPROMISING SAFETY AND EFFICIENCY AND HAS THE POTENTIAL TO IMPROVE FIRST-PASS ISOLATION USING 90-W HPSD ABLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VIZIGO STEERABLE SHEATH AND QDOT CATHETER. OTHER BWI DEVICE(S): CARTO-3 MAPPING SYSTEM, NGEN RF GENERATOR, DECANAV CATHETER, PENTARAY CATHETER, VISITAG. OTHER NON-BWI DEVICE(S): SENSITHERM (ABBOTT) PROBE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_CARTO VIZIGO SHEATH: QTY: 1 CASE OF GROIN AV FISTULA TREATED CONSERVATIVELY. QTY: 2 CASES OF PSEUDO-ANEURYSMS TREATED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735983 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO-3 MAPPING SYSTEM.| DECANAV CATHETER.| NGEN RF GENERATOR.| PENTARAY CATHETER.| SENSITHERM (ABBOTT) PROBE.| VISITAG.