BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTARAY NAV

    MDR report key: 23752443 · Received December 8, 2025

    Report

    Report Number
    2029046-2025-04050
    Event Type
    Death
    Date Received
    December 8, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND THE PATIENT EXPERIENCED ACUTE MYOCARDIAL INFARCTION AND ULTIMATELY DIED. AFTER ISOLATION OF THE RIGHT PULMONARY VEINS, DURING ABLATION OF THE LEFT PULMONARY VEINS, THE PATIENT DEVELOPED ASYSTOLE AND BECAME MARKEDLY OBTUNDED AND UNRESPONSIVE. SURFACE ELECTROCARDIOGRAM (ECG) SHOWED PRONOUNCED ST-SEGMENT ELEVATION AND THE HEART RATE PROGRESSIVELY SLOWED. VENTRICULAR PACING AND ELECTRICAL CARDIOVERSION WERE PERFORMED, BUT THE ST ELEVATION PERSISTED, SUGGESTING AN ACUTE MYOCARDIAL INFARCTION. APPROXIMATELY 5¿10 MINUTES LATER, THE PATIENT WENT INTO CARDIAC ARREST. VENTRICULAR PACING FAILED TO CAPTURE, AND CHEST COMPRESSIONS WERE STARTED. DURING RESUSCITATION, IT WAS NOTED THAT THE INFUSION LINE CONNECTED TO THE PENTARAY, AND THE SALINE BAG INSIDE THE PRESSURE BAG, CONTAINED NO HEPARINIZED SALINE. THE SALINE BAG HAD COMPLETELY COLLAPSED (A NEW SALINE BAG CONTAINS 500 ML NORMAL SALINE PLUS ABOUT 50 ML OF AIR). THE SALINE BAG HAD NOT BEEN REPLACED SINCE THE PREVIOUS CASE (6 HOURS EARLIER). CRANIAL CT SHOWED A LARGE NUMBER OF AIR BUBBLES IN THE BRAIN. THE CORONARY TEAM THEN PERFORMED ANGIOGRAPHY, WHICH REVEALED AN ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION. RESUSCITATION WAS UNSUCCESSFUL. THE PATIENT UNDERWENT RADIOFREQUENCY ABLATION FOR PERSISTENT ATRIAL FIBRILLATION. AFTER FEMORAL VENOUS PUNCTURE, LEFT ATRIAL CEREBROSPINAL FLUID (CSF) MAPPING WAS PERFORMED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). UNDER ICE AND FLUOROSCOPIC GUIDANCE, A TRANSSEPTAL PUNCTURE WAS PERFORMED. TWO PUNCTURES WERE MADE SUCCESSFULLY AND THE THERMOCOOL SMARTTOUCH (STSF) CATHETER AND PENTARAY WERE PLACED INTO THE LEFT ATRIUM. ABLATION BEGAN AS USUAL. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS ¿THERE ARE DOUBTS ABOUT PENTARAY PRESSURIZED GAS ENTERING THE BODY¿. THE INTERVENTION PROVIDED WAS ¿RESCUE¿. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE OTHER RELEVANT HISTORY/PRE-EXISTING CONDITION WAS DYSPNEA, CORONARY ATHEROSCLEROSIS, HYPERTENSION, DIABETES, DIABETES FOOT, RENAL INSUFFICIENCY, AND HEMATURIA. ONE SHEATH AND THE CATHETER EXCHANGE WAS REPORTED. THE ENERGY USED WAS RADIOFREQUENCY (RF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760945 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R| L THMCL SMTCH SF UNID, TC, F, IL