BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 24076791 · Received January 14, 2026

    Report

    Report Number
    2029046-2026-00169
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    October 22, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TOGASHI D, KATSUME Y, ALAHWANY SH, DAVOGUSTTO GE, YONEDA ZT, RICHARDSON TD, MONTGOMERY JA, SHEN S, ESTRADA JC, KANAGASUNDRAM AN, TANDRI H, STEVENSON WG. ELECTRODE THERMAL PROFILE DURING VENTRICULAR RF ABLATION: A NOVEL INDICATION OF ELECTRODE TISSUE INTERFACE TO INFORM ENERGY DELIVERY. JACC CLIN ELECTROPHYSIOL. 2025 OCT 22:S2405-500X(25)00735-2. DOI: 10.1016/J.JACEP.2025.09.008. EPUB AHEAD OF PRINT. PMID: 41134243. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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 NO LOT NUMBER WAS 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. MANUFACTURER'S REF#: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TOGASHI D, KATSUME Y, ALAHWANY SH, DAVOGUSTTO GE, YONEDA ZT, RICHARDSON TD, MONTGOMERY JA, SHEN S, ESTRADA JC, KANAGASUNDRAM AN, TANDRI H, STEVENSON WG. ELECTRODE THERMAL PROFILE DURING VENTRICULAR RF ABLATION: A NOVEL INDICATION OF ELECTRODE TISSUE INTERFACE TO INFORM ENERGY DELIVERY. JACC CLIN ELECTROPHYSIOL. 2025 OCT 22:S2405-500X(25)00735-2. DOI: 10.1016/J.JACEP.2025.09.008. EPUB AHEAD OF PRINT. PMID: 41134243. BACKGROUND: ELECTRODE¿TISSUE CONTACT AND ORIENTATION INFLUENCE RADIOFREQUENCY (RF) ABLATION HEATING, LESION SIZE, AND STEAM POPS, AND IS NOT EASILY ASSESSED. A CATHETER WITH 6 DISTAL ELECTRODE TEMPERATURE SENSORS PROVIDES THERMAL PROFILES THAT MAY HELP CLARIFY ELECTRODE¿TISSUE INTERACTIONS. OBJECTIVE: THE AIM OF THIS STUDY WAS TO EVALUATE THE RELATIONSHIPS BETWEEN THERMAL PROFILES, CATHETER ORIENTATION, IMPEDANCE FALL, STEAM POPS, AND DISCORDANT TEMPERATURE¿IMPEDANCE CHANGES DURING VENTRICULAR RF ABLATION. METHODS: WE ANALYZED 2,085 RF APPLICATIONS IN 100 PATIENTS, TITRATING POWER TO A MAXIMUM TEMPERATURE < 50 °C AND IMPEDANCE FALL > 10 O. STABLE THERMAL PROFILES WERE CLASSIFIED AS EMBEDDED, CENTRAL, OR PERIPHERAL. CATHETER ORIENTATION FROM THE FORCE VECTOR WAS CLASSIFIED AS PERPENDICULAR, OBLIQUE, OR PARALLEL. CONCLUSIONS: ELECTRODE THERMAL PROFILES PROVIDE INFORMATION COMPLEMENTARY TO FORCE VECTOR AND IMPEDANCE, REFLECTING ELECTRODE¿TISSUE INTERACTIONS THAT ARE ALSO RELATED TO DISCREPANCIES IN IMPEDANCE FALL AND TEMPERATURE DURING RF ABLATION. THEY CAN POTENTIALLY HELP OPTIMIZE RF ABLATION LESION SIZE WHILE AVOIDING STEAM POPS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING QDOT CATHETER (BIOSENSE WEBSTER) OTHER BWI PRODUCTS: CARTO SYSTEM (BIOSENSE WEBSTER), INTRACARDIAC ECHOCARDIOGRAPHY [ICE] CATHETER (SOUNDSTAR; BIOSENSE WEBSTER), NGEN RF GENERATOR (BIOSENSE WEBSTER). NON-BWI DEVICES: CARDIOLAB EP SYSTEM (GE HEALTHCARE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: CARDIAC TAMPONADE. NO INTERVENTION MENTIONED. QTY 1: ARTERIOVENOUS FISTULA. NO INTERVENTION MENTIONED. QTY 1: TRANSIENT ISCHEMIC ATTACK. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137631 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARDIOLAB EP SYSTEM (GE HEALTHCARE).| UNK_CARTO 3.| UNK_NGEN RF GENERATOR.| UNK_SOUNDSTAR.