BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 23453494 · Received November 3, 2025

    Report

    Report Number
    2029046-2025-03674
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 06-NOV-2025. CONFIRMED THAT AT THE TIME HE INITIALLY CALLED ON 21-OCT-2025, HE WAS IN A CASE AND HAD TO DROP THE CALL. THEREFORE, CALLED THE FOLLOWING DAY 22-OCT-2025 TO PROVIDE THE REMAINING INFORMATION ON THE EVENT. THE PATIENT WENT INTO THE ER ABOUT 3 WEEKS AFTER THE PROCEDURE DATE OF (B)(6) 2025. DID NOT HAVE THE EXACT EVENT DATE AND THEREFORE PROVIDED OCT 2025. IT DID NOT PENETRATE DEEP ENOUGH TO GO INTO THE ATRIUM; THEREFORE, THE EVENT WAS AN ESOPHAGEAL PERICARDIAL FISTULA. DOES NOT HAVE LOT OR CATALOG # FOR THE QDOT MICRO CATHETER SINCE IT WAS 3 WEEKS AFTER THE PROCEDURE. THE SPECIFIC DATE OF THE EVENT WAS 17-SEPT-2025. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS USING QDOT ON THE POSTERIOR WALL. THE INTERVENTION PROVIDED WAS THE ESOPHAGUS WAS PATCHED, AND PERICARDIAL SAC OF THE HEART WAS FLUSHED OUT MULTIPLE TIMES. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS IN THE INTENISVE CARE UNIT (ICU) FOR AN EXTENDED PERIOD. RELEVANT TESTS/LABORATORY DATA WAS CT SCAN OF CHEST SHOWED FLUID IN PERICARDIAL SPACE. AFTER INTERVENTION BARIUM SWALLOW SHOWED NO LEAKAGE OF ESOPHAGUS TO PERICARDIAL SAC. NGEN GENERATOR WAS USED IN QMODE PLUS. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE MODALITIES USED TO PREVENT ESOPHAGEAL INJURY WAS TEMPERATURE PROBE. THE ESOPHAGEAL INJURY CONFIRMED THAT THE PATIENT WENT TO THE HOSPITAL AND HAD FLUID IN THE THORACIC SPACE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR AND VISITAG. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WAS QMODE PLUS. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. SINCE THE EVENT DATE WAS PROVIDED OF 17-SEP-2025, PROCESSED B3. DATE OF EVENT. ADDITIONALLY PROVIDED THE PATIENT¿S SEX, GENDER AND WEIGHT. HENCE, PROCESSED THE FOLLOWING FIELDS: -A3A. SEX. -A3B. GENDER. -A4. WEIGHT OF THE PATIENT. -A4. WEIGHT UNIT. 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

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 FIBRILLATION (AFIB) PROCEDURE WITH A QDOT MICRO CATHETER AND AN NGEN GENERATOR AND SUFFERED AN ESOPHAGEAL PERICARDIAL FISTULA WHICH REQUIRED AN ESOPHAGUS PATCH AND THE PERICARDIAL SAC FLUSHED. THE PATIENT HAD AN ESOPHAGEAL PERICARDIAL FISTULA. THE FISTULA DID NOT GO ALL THE WAY TO THE ATRIUM. THE PATIENT WENT INTO THE EMERGENCY ROOM (ER) IN (B)(6) 2025 ABOUT 2-3 WEEKS FOLLOWING THE PROCEDURE. UNABLE TO PROVIDE DETAILS ABOUT THE PATIENT SYMPTOMS AND UNSURE WHAT SPECIFIC DATE THE PATIENT CAME INTO THE ER. THE EVENT WAS REPORTED TO THE JNJ REPRESENTATIVE ON 08-OCT-2025. FLUID WAS NOTICED IN THE THORACIC SPACE. IT WAS UNKNOWN HOW THE INJURY WAS CONFIRMED, AND MORE TESTING WAS PERFORMED. THE ESOPHAGUS WAS PATCHED UP AND THE PERICARDIAL SAC HAD TO BE FLUSHED OUT A FEW TIMES. THE PATIENT'S PERICARDIAL SAC HAD TO BE FLUSHED OUT BECAUSE THE FISTULA IN THE ESOPHAGUS WAS LEAKING FLUID AND ACIDS INTO THE PERICARDIAL SAC. THE LAST KNOWN PATIENT STATUS WAS ALIVE AND DISCHARGED. A QDOT MICRO CATHETER WAS USED FOR ABLATION. QMODE PLUS WAS USED. THE NGEN GENERATOR WAS USED FOR ABLATION AND CARTO 3 SYSTEM WAS USED FOR MAPPING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE QDOT MICRO CATHETER AND THE NGEN GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758782 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R CARTO 3 SYSTEM| NGEN RF GENERATOR, US