BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NAV

    MDR report key: 24072734 · Received January 14, 2026

    Report

    Report Number
    2029046-2026-00160
    Event Type
    Injury
    Date Received
    January 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: BORGES AP, KALIL C, BRUGADA J, YANEZ JPG, SOLIZ PDC, BOFF CO, ORSATO P, SALDANHA PF, RÖSLER Á, DE MATTOS AZ, SAFFI MAL, DA SILVEIRA AD, PIMENTEL M. A PREDICTIVE MODEL FOR ESOPHAGEAL THERMAL INJURY FOLLOWING ATRIAL FIBRILLATION ABLATION : RISK TOOL FOR ESOPHAGEAL THERMAL INJURY. J INTERV CARD ELECTROPHYSIOL. 2025 NOV 5. DOI: 10.1007/S10840-025-02174-W. EPUB AHEAD OF PRINT. PMID: 41191315. 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: BORGES AP, KALIL C, BRUGADA J, YANEZ JPG, SOLIZ PDC, BOFF CO, ORSATO P, SALDANHA PF, RÖSLER Á, DE MATTOS AZ, SAFFI MAL, DA SILVEIRA AD, PIMENTEL M. A PREDICTIVE MODEL FOR ESOPHAGEAL THERMAL INJURY FOLLOWING ATRIAL FIBRILLATION ABLATION : RISK TOOL FOR ESOPHAGEAL THERMAL INJURY. J INTERV CARD ELECTROPHYSIOL. 2025 NOV 5. DOI: 10.1007/S10840-025-02174-W. EPUB AHEAD OF PRINT. PMID: 41191315. BACKGROUND AND AIMS: ATRIOESOPHAGEAL FISTULA (AEF) IS A RARE BUT SERIOUS COMPLICATION OF ATRIAL FIBRILLATION (AF) ABLATION, LINKED TO HIGH MORBIDITY AND MORTALITY. ESOPHAGEAL THERMAL INJURY (ETI), A PRECURSOR TO AEF, HIGHLIGHTS THE NEED TO IDENTIFY HIGH-RISK PATIENTS. THIS STUDY AIMS TO ASSESS PREDICTORS OF ETI FOLLOWING AF ABLATION. METHODS: THIS PROSPECTIVE COHORT STUDY INCLUDED PATIENTS UNDERGOING THEIR FIRST RADIOFREQUENCY AF ABLATION BETWEEN OCTOBER 2018 AND JUNE 2024. ESOPHAGEAL TEMPERATURE WAS CONTINUOUSLY MONITORED USING A MULTI-SENSOR PROBE. RF ENERGY ON THE POSTERIOR LEFT ATRIAL (LA) WALL WAS DELIVERED AT 40 W FOR UP TO 12 S AND INTERRUPTED IF TEMPERATURE REACHED = 38 °C. UPPER ENDOSCOPY WITHIN 48 H POST-PROCEDURE CLASSIFIED ETI ACCORDING TO THE KANSAS CITY CLASSIFICATION. CONCLUSIONS: SMALLER LA DIAMETER AND ELEVATED ESOPHAGEAL TEMPERATURE DURING AF ABLATION INDEPENDENTLY PREDICT ETI. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED TIP CATHETER WITH CONTACT FORCE TECHNOLOGY (THERMOCOOL SMARTTOUCH SF). OTHER BWI DEVICE(S): CARTO SYSTEM CATHETER (LASSO NAV OR PENTARAY). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR THERMOCOOL SF NAV DEVICE(S): QTY: (B)(4), PATIENT EXPERIENCED ESOPHAGEAL THERMAL INJURY AND KCC TYPE 2B INJURY AND UNDERWENT A SECOND ENDOSCOPY 72 H FOLLOWING THE INITIAL PROCEDURE. DUE TO THE LACK OF IMPROVEMENT IN THE APPEARANCE OF THE LESION, A NASOENTERAL TUBE WAS PLACED. A CHEST CT SCAN WAS PERFORMED, WHICH DID NOT REVEAL ANY MAJOR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127522 THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK_LASSO| UNK_PENTARAY