BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUPULSE GENERATOR

    MDR report key: 25194773 · Received May 15, 2026

    Report

    Report Number
    2029046-2026-01592
    Event Type
    Death
    Date Received
    May 15, 2026
    Date of Event
    April 17, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025231
    PMA / PMN Number
    P240006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. E1. INITIAL REPORTER PHONE: (B)(6). 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: THE DUAL ENERGY SMART TOUCH BIDIRECTIONAL SF CATHETER HAS NOT BEEN APPROVED BY US FDA AND IS NOT MARKETED IN THE US. IT IS ALSO NOT A SIMILAR PRODUCT TO ANY MARKETED BWI PRODUCTS. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    PATIENT RECEIVED AN INDEX CARDIAC ABLATION PROCEDURE WITH A TRUPULSE GENERATOR FOR ISCHEMIC VENTRICULAR TACHYCARDIA ON (B)(6) 2026. ON (B)(6) 2026, PATIENT EXPERIENCED RIGHT VENTRICLE (RV) PERFORATION FOLLOWING STEAM POP FROM ABLATION DEVICE (ADVERSE EVENT #1) CATEGORIZED AS SEVERE AND SERIOUS DEFINED BY DEATH / LIFE-THREATENING ILLNESS OR INJURY / PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION / MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION / HOSPITALIZATION WITH AN ADMISSION DATE OF (B)(6) 2026 AND A DISCHARGE DATE OF (B)(6) 2026. RELATIONSHIP TO STUDY DEVICE (B)(4) IS CAUSAL AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS CAUSAL. THE ADVERSE EVENT IS UNANTICIPATED. THE REPORTED OUTCOME WAS REPORTED AS DEATH (DATE OF DEATH (B)(6) 2026). INTERVENTION WAS MEDICATION (NORADRENALINE, ADRENALINE, SODIUM BICARBONATE, MAGNESIUM SULFATE), SURGERY (STERNOTOMY, AND RV PERFORATION REPAIR DONE). THE FOLLOWING WAS REPORTED ABOUT THE EVENT: THERE WAS INCREASED IMPEDANCE NOTED AFTER STEAM POP, LEADING TO RV PERFORATION. PATIENT HAD CARDIAC TAMPONADE WITH SUDDEN PRESSURE DROP. CARDIOPULMONARY RESUSCITATION (CPR) WAS INTERRUPTED AS ATTEMPTS WERE MADE FOR PERICARDIOCENTESIS. ONGOING DRAINING WHILE THE SURGEON ARRIVED. PERFORATION WAS REPAIRED BUT PATIENT DETERIORATED. PALLIATIVE CARE WAS INCORPORATED. PATIENT DIED (B)(6) 2026. THE DUAL ENERGY SMART TOUCH BIDIRECTIONAL SF CATHETER (LOT # 31667254L) IN USE WITH THE TRUPULSE GENERATOR HAD A STEAM POP. THE STEAM POP OCCURRED WHILE ABLATING AT 45 WATTS WITH RF (RADIOFREQUENCY). ADDITIONALLY, IT WAS REPORTED THERE WAS A DEFICIENCY WITH A DUAL ENERGY SMART TOUCH BIDIRECTIONAL SF CATHETER (LOT # 31655006L). THIS CATHETER DELIVERED NO ENERGY PER CLINICAL DATABASE. WHEN THE CATHETER WAS INTRODUCED INTO THE PATIENT, THEY NOTICED CONTINUOUS NOISE ON THE DISTAL ELECTRODE CHANNEL. THEY CHANGED CABLE BUT IT DIDN'T HELP. A NEW CATHETER WAS TAKEN, AND IT SOLVED THIS ISSUE. THIS WAS NOTED ON BOTH THE CARTO AND EP RECORDING SYSTEM. DELAY OF 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92018 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