BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPULSE¿ GENERATOR

    MDR report key: 21944978 · Received May 1, 2025

    Report

    Report Number
    2029046-2025-01400
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    PMA / PMN Number
    P240006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER AND H4. DEVICE MANUFACTURE DATE HAVE BEEN ADDED. THE INVESTIGATION WAS COMPLETED ON 28-SEP-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE WAS ONSITE FOR TROUBLESHOOTING. AFTER DOCKING STATION CONNECTIONS WERE SECURED, THE TRUPULSE¿ GENERATOR BOOTED UP FINE INITIALLY. THEN THERE WAS A LOUD NOISE AND A SMOKE SMELL COMING FROM THE TRUPULSE¿ GENERATOR. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE DISCONNECTED POWER FROM THE TRUPULSE¿ GENERATOR. THE TRUPULSE¿ GENERATOR WAS NO LONGER TURNING ON. REPLACEMENT GENERATOR NEEDED. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE NOTICED SHOCK AND TILT STICKERS WERE ACTIVATED ON THE WRAPPING. TECHNICAL SERVICES PERFORMED AN EVALUATION AT THE DEVICE LOCATION SITE. WORK ORDER SERVICE REPORT WAS SENT TO JOHNSON & JOHNSON MEDTECH FOR EVALUATION. THE FAILURES REPORTED IN THE EVENT WERE CONFIRMED. PER THE SYSTEM CONDITIONS OBSERVED, IT WAS DECLARED DEAD ON ARRIVAL (DOA) AND PUT OUT OF SERVICE. NO FURTHER EVALUATION ON THE REPLACED SYSTEM WAS PERFORMED AT THIS TIME. IT SHOULD BE NOTED THAT THIS ISSUE OCCURRED DURING SYSTEM INSTALLATION. ADDITIONALLY, A WORK ORDER HISTORY REVIEW WAS PERFORMED, AND NO FURTHER ISSUES REGARDING SMOKE/BURNING SMELL WERE FOUND. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF THE QUALITY PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND THERE WAS A SMOKE SMELL ISSUE. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE WAS ONSITE FOR TROUBLESHOOTING. AFTER DOCKING STATION CONNECTIONS WERE SECURED, THE TRUPULSE¿ GENERATOR BOOTED UP FINE INITIALLY. THEN THERE WAS A LOUD NOISE AND A SMOKE SMELL COMING FROM THE TRUPULSE¿ GENERATOR. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE DISCONNECTED POWER FROM THE TRUPULSE¿ GENERATOR. THE TRUPULSE¿ GENERATOR WAS NO LONGER TURNING ON. REPLACEMENT GENERATOR NEEDED. THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE NOTICED SHOCK AND TILT STICKERS WERE ACTIVATED ON THE WRAPPING. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THAT THERE WAS NO FIRE, JUST BURNING WIRE SMELLS. THE UNIT WAS NEVER USED IN A CASE OR WITH A PATIENT. THEY WERE SETTING IT UP. THE NOISE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE SMOKE SMELL WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309766 TRUPULSE¿ GENERATOR PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown