BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPULSE¿ GENERATOR

    MDR report key: 24948332 · Received April 21, 2026

    Report

    Report Number
    2029046-2026-01306
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025231
    PMA / PMN Number
    P240006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2026 WHICH INDICATED THAT THERE WAS NO PERFORATION/MYOCARDIAL INJURY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO TRUPULSE¿ GENERATOR APPROVED UNDER P240006. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 ATRIAL FLUTTER (AFL) PROCEDURE WITH A TRUPULSE¿ GENERATOR AND A STEAM POP ISSUE WAS OBSERVED. IT WAS REPORTED THAT THERE WAS A STEAM POP (EXPLOSION OF THE TISSUE) DURING ABLATION ON THE INTERIOR OF THE LEFT ATRIUM. THERE WAS A RUPTURE OF THE TISSUE, SUPERFICIAL NOT VISIBLE. AFTER CHECKING THE VITAL SIGNALS, THERE WAS NO PATIENT CONSEQUENCE VISIBLE. NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED. A DUAL ENERGY SMART TOUCH WAS INVOLVED IN THE ABLATION PROCESS. RADIO FREQUENCY ENERGY WAS BEING USED WHEN THE STEAM POP OCCURRED. THE RADIO FREQUENCY AND PFA ENERGY WERE USED EARLIER IN THE PROCEDURE BEFORE THE STEAM POP. TWO INDIFFERENT ELECTRODES WERE USED AT THE TIME OF USING RADIO FREQUENCY. POWER SETTING DURING THE RADIO FREQUENCY ABLATION WAS 40 WATTS. GENERATOR USED POWER CONTROL MODE. THE NOTED TEMPERATURE, IMPEDANCE AND POWER WERE 26-28C, 158-147OHM, 40W. THE LENGTH (MINUTES AND SECONDS) OF THE ABLATION CYCLE WHEN THE POP WAS OBSERVED AT THE SAME TIP POSITION WAS 20S, REST OF APPLICATIONS IN 4.1-5.2MM DISTANCE. NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327809 TRUPULSE¿ GENERATOR PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 10846835025231

    Patients

    Seq Age Sex Outcome Treatment
    1