BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 20517440 · Received October 23, 2024

    Report

    Report Number
    2029046-2024-03447
    Event Type
    Death
    Date Received
    October 23, 2024
    Date of Event
    August 13, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017076
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2. DATE OF DEATH - THE EXACT DATE OF DEATH IS UNKNOWN AT THIS TIME AND SO THIS FIELD WAS POPULATED WITH THE AWARENESS DATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. 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. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2025. IT WAS REPORTED THAT THE PHYSICIAN'S OPINION ON THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK WITH UPPER GASTROINTESTINAL BLEEDING. ESOPHAGEAL INJURY WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. AS SUCH, THE CODE OF HEMORRHAGE/BLEEDING (E0506) WAS ADDED TO H 6. HEALTH EFFECT - CLINICAL CODE. PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 300. AN NGEN GENERATOR WITH QMODE PLUS WAS USED. NO ERROR MESSAGES DURING THE PROCEDURE. MODALITIES USED TO PREVENT ESOPHAGEAL INJURY WERE FORCE, IMPEDANCE AND XRAY. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. IRRIGATION WAS ON AUTOMATIC. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FOLLOWING SECTIONS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: CONCOMITANT PRODUCT SECTION AND PATIENT INFORMATION SECTION. 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 PULMONARY VEIN ISOLATION PROCEDURE, AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. A PATIENT DIED OF AN ESOPHAGEAL FISTULA A FEW DAYS AFTER PULMONARY VEIN ISOLATION WITH ADDITIONAL ROOF AND POSTERIOR LINE TRACTION. THE MEDICAL TEAM SUSPECTED THAT THE EXISTING AORTIC VALVE PROSTHESIS MAY HAVE BECOME HEATED DURING ABLATION OF THE POSTERIOR WALL, WHICH COULD HAVE CAUSED THE FISTULA TO FORM. HOWEVER, THEY ARE NOT CERTAIN. THE PATIENT ALREADY HAD SEVERAL PREVIOUS ILLNESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375089 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835017076

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death| L NGEN PUMP, EU CONFIGURATION| UNK TRANSSEPTAL NEEDLE| UNK_CARTO 3| UNK_NGEN RF GENERATOR