BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTARAY NAV

    MDR report key: 23187388 · Received September 30, 2025

    Report

    Report Number
    2029046-2025-03316
    Event Type
    Death
    Date Received
    September 30, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT: 31653934L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA - LEFT (L-ISVT) PROCEDURE WITH A PENTARAY NAV CATHETER AND SUFFERED A VENTRICULAR FIBRILLATION WHICH REQUIRED CARDIOVERSION, CARDIAC MASSAGE AND ADMINISTERED DRUGS; HOWEVER, THE PATIENT SUBSEQUENTLY DIED. DURING A VT PROCEDURE, A SUSTAINED VT WAS INDUCED RELATIVELY WELL TOLERATED. AFTER MAPPING THE ARRHYTHMIA, DOCTORS DECIDED TO TERMINATE THE TACHYCARDIA WITH STIMULATION. THAT DID NOT WORK, SO THEY DECIDED TO DO A CARDIOVERSION. CARDIOVERSION PUT THE PATIENT INTO VENTRICULAR FIBRILLATION. THEY TRIED SEVERAL ATTEMPTS OF ELECTRICAL CARDIOVERSION WHILE PERFORMING CARDIAC MASSAGE AND ADMINISTRATING DRUGS. HOWEVER, THE PATIENT COULD NOT RECOVER TO SINUS RHYTHM AND DIED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS DECOMPENSATION OF THE HEART AFTER THE ELECTRICAL CARDIOVERSION. NO BIOSENSE WEBSTER, INC. ABLATION CATHETER USED FOR ABLATION PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795248 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31653934L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| R UNKNOWN STIMULATOR.