BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 22347010 · Received June 27, 2025

    Report

    Report Number
    2029046-2025-02106
    Event Type
    Death
    Date Received
    June 27, 2025
    Date of Event
    June 3, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016741
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: FOR FIELD D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 DURING AND AFTER ATRIAL FIBRILLATION ABLATION WITH QDOT MICRO AND THE PATIENT EXPERIENCED HYPOTENSION DURING AND AFTER THE PROCEDURE, AND AFTER TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND THE PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY WITHIN THE NIGHT AFTER UNDERGOING CARDIAC ABLATION. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE PERICARDIAL SPACE WAS EVALUATED WITH THE INTRACARDIAC ECHO CATHETER (ICE). NO PERICARDIAL EFFUSION WAS SEEN ON THE ICE IMAGES. THE ANESTHESIA TEAM TREATED BLOOD PRESSURE ISSUES WITH MEDICATION AND THE PROCEDURE WAS CONTINUED. AT ONE POINT IN THE PROCEDURE, AIR WAS NOTICED WITHIN THE BOSTON SCIENTIFIC FARADRIVE SHEATH. THE PHYSICIAN REMOVED THE AIR AND THE PROCEDURE WAS CONTINUED. AFTER THE ABLATION, THE PATIENT WAS STABLE AND TRANSPORTED TO THE POST OPERATIVE AREA. IT WAS THERE THAT THE PATIENT EXHIBITED SIGNS OF EXTENSIVE HYPOTENSION. THERE WAS LIMITED INFORMATION REGARDING THE EVENT DETAILS INCLUDING MEDICAL INTERVENTIONS THAT WERE PROVIDED TO THE PATIENT. THE PATIENT WAS LATER TRANSPORTED TO THE INTENSIVE CARE UNIT AND LATER PASSED AWAY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS RE-INTUBATED AND SENT TO THE ICU. THE PHYSICIAN¿S OPINION OF THE CAUSE OF DEATH WAS UNKNOWN, POSSIBLY PATIENT RELATED. THE OTHER CATHETER USED FOR ABLATION ON THE LEFT ATRIAL SIDE WAS THE BS FARAPULSE CATHETER, AND THE QDOT FJ CURVE WAS USED ONLY FOR THE CTI LINE. FORCE SENSING ABLATION CATHETER WAS USED, AND FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR, AND VISITAG. VISITAG MODULE PARAMETERS FOR STABILITY USED WERE 3,3,3 SURPOINT RECOMMENDED SETTINGS. ADDITIONAL FILTER USED WITH THE VISITAG WAS RESPIRATION, AND COLOR OPTION USED PROSPECTIVELY WAS SURPOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939589 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| D| H BOSTON SCIENTIFIC FARADRIVE SHEATH| BOSTON SCIENTIFIC FARAPULSE CATHETER| CARTO 3 SYSTEM| NGEN RF GENERATOR, US