BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NAV

    MDR report key: 22307771 · Received June 23, 2025

    Report

    Report Number
    2029046-2025-02045
    Event Type
    Injury
    Date Received
    June 23, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: LU X, QIN T, ZHOU H, XIONG G, LUO L, QIN Z. SUCCESSFUL TREATMENT OF A PATIENT WITH HEPATIC PORTAL VEIN GAS AFTER RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION: A CASE REPORT. CURR MED IMAGING. 2024;20: E15734056341816. DOI: 10.2174/0115734056341816240829060516. PMID: 39225200. 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: LU X, QIN T, ZHOU H, XIONG G, LUO L, QIN Z. SUCCESSFUL TREATMENT OF A PATIENT WITH HEPATIC PORTAL VEIN GAS AFTER RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION: A CASE REPORT. CURR MED IMAGING. 2024;20:E15734056341816. DOI: 10.2174/0115734056341816240829060516. PMID: 39225200. BACKGROUND: TRANSCATHETER RADIOFREQUENCY ABLATION IS ONE OF THE MAIN TREATMENTS FOR ATRIAL FIBRILLATION, BUT RELATED COMPLICATIONS OF THIS SURGERY ARE UNCOMMON. IN THIS ARTICLE, A CASE OF AN ELDERLY MALE WITH ATRIAL FIBRILLATION (AF) WHO DEVELOPED HEPATIC PORTAL VEIN GAS (HPVG) ON THE DAY AFTER RADIOFREQUENCY ABLATION OF AF WAS REPORTED. ON OCTOBER 18, 2023, THE PATIENT UNDERWENT ELECTROPHYSIOLOGICAL EXAMINATION AND RADIOFREQUENCY CATHETER ABLATION, WITH DELIVERY TO THE CORONARY SINUS CATHETER AND SHEATH TO THE LEFT ATRIUM (LA), INTO THE ABLATION CATHETER NAVI STAR THERMO-COOL SMART TOUCH ABLATION CATHETER) AND THE PENTARAY CALIBRATION ELECTRODES CATHETER, USING THE CARTO 3D MAPPING SYSTEM GUIDANCE. ONE HOUR AFTER THE SURGERY, THE PATIENT EXPERIENCED SIGNIFICANT ABDOMINAL PAIN AS PER THE ABDOMINAL CT FINDINGS. MULTIPLE GAS ACCUMULATIONS IN THE INTRAHEPATIC PORTAL VEIN AND MULTIPLE BRANCHES IN THE SUPERIOR MESENTERIC VEIN WERE OBSERVED. THE PATIENT WAS SUCCESSFULLY MANAGED WITH CONSERVATIVE TREATMENT, SUCH AS FASTING, GASTROINTESTINAL DECOMPRESSION, SPASMOLYSIS, PAIN RELIEF, SOMATOSTATIN INHIBITION OF INTESTINAL EDEMA, ANTIINFECTION, AND ANTICOAGULATION. THE PATIENT'S CONDITION IMPROVED, AND WAS DISCHARGED. FOLLOWED THE PATIENT FOR 1 MONTH AFTER DISCHARGE, AND THERE WAS NO SPECIAL DISCOMFORT. CONCLUSION: HEPATOPORTAL VEIN GAS ACCUMULATION AFTER RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION IS RARE, AND IMAGING FINDINGS HAVE IMPORTANT GUIDING SIGNIFICANCE FOR THE DIAGNOSIS AND TREATMENT OF THE DISEASE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTAR THERMO-COOL SMART TOUCH ABLATION CATHETER. OTHER BWI DEVICES: PENTARAY CALIBRATION ELECTRODES CATHETER, USING THE CARTO 3D MAPPING SYSTEM GUIDANCE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_NAVISTAR THERMOCOOL: A 70-YEAR-OLD ELDERLY MALE EXPERIENCED SEVERE ABDOMINAL PAIN EARLY AFTER UNDERGOING RADIOFREQUENCY ABLATION; RELATED IMAGING EXAMINATIONS SUGGESTED THAT THE PATIENT HAD INTESTINAL EDEMA AND THICKENING, COMBINED WITH HEPATIC PORTAL VEIN GAS (HPVG) ACCUMULATION. THE REASON WAS THAT THE PATIENT EXPERIENCED INTESTINAL NECROSIS DUE TO SUPERIOR MESENTERIC ARTERY EMBOLISM RELATED TO RADIOFREQUENCY SURGERY. THE PATIENT WAS SUCCESSFULLY MANAGED WITH CONSERVATIVE TREATMENT, SUCH AS FASTING, GASTROINTESTINAL DECOMPRESSION, SPASMOLYSIS, PAIN RELIEF, SOMATOSTATIN INHIBITION OF INTESTINAL EDEMA, ANTI-INFECTION, AND ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927619 THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening