BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 22562359 · Received July 21, 2025

    Report

    Report Number
    2029046-2025-02399
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 26, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    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

    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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A REDO ATRIAL FLUTTER AND ATRIAL FIBRILLATION ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED A RIGHT ATRIAL CLOT WITHOUT ANY MEDICAL TREATMENTS. DURING A REDO ATRIAL FLUTTER AND ATRIAL FIBRILLATION CASE, A "RIGHT ATRIAL CLOT" WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT WAS NOTICED AFTER THE CAVOTRICUSPID ISHMUS (CTI) LINE ABLATION. AT BASELINE ICE IMAGES WERE TAKEN (PRIOR TO ANY ABLATION) AND THE IMAGES DID NOT SHOW A CLOT, AND THEY DID NOT CONFIRM THE CLOT WITH ANY OTHER MODALITY BESIDES ICE. THE PHYSICIAN DECIDED NOT TO GO TRANSEPTAL TO THE LEFT ATRIUM AND THE ATRIAL FIBRILLATION PORTION OF THE PROCEDURE WAS ABORTED. NO MEDICAL INTERVENTION FOR THE CLOT WAS PROVIDED. A CARDIOVERSION WAS PERFORMED AND THE PATIENT WAS IN NORMAL SINUS RHYTHM. THE PATIENT IS STABLE. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING JOHNSON & JOHNSON MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED. NO MAGNETIC, FORCE, IRRIGATION, DEFLECTION, TEMPERATURE OR ELECTRICAL ISSUES WERE FOUND DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 29-JUL-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REDO ATRIAL FLUTTER AND ATRIAL FIBRILLATION ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED A RIGHT ATRIAL CLOT WITHOUT ANY MEDICAL TREATMENTS. DURING A REDO ATRIAL FLUTTER AND ATRIAL FIBRILLATION CASE, A "RIGHT ATRIAL CLOT" WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT WAS NOTICED AFTER THE CAVOTRICUSPID ISHMUS (CTI) LINE ABLATION. AT BASELINE ICE IMAGES WERE TAKEN (PRIOR TO ANY ABLATION) AND THE IMAGES DID NOT SHOW A CLOT, AND THEY DID NOT CONFIRM THE CLOT WITH ANY OTHER MODALITY BESIDES ICE. THE PHYSICIAN DECIDED NOT TO GO TRANSEPTAL TO THE LEFT ATRIUM AND THE ATRIAL FIBRILLATION PORTION OF THE PROCEDURE WAS ABORTED. NO MEDICAL INTERVENTION FOR THE CLOT WAS PROVIDED. A CARDIOVERSION WAS PERFORMED AND THE PATIENT WAS IN NORMAL SINUS RHYTHM. THE PATIENT IS STABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574098 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31589228L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO 3 SYSTEM.| NGEN RF GENERATOR, US.| OCTA,STD,48P,2-2-2-2-2,D-CURVE.| UNK_C3 CS REFSTAR - DEFLECTABLE.| UNK_CARTO VIZIGO SHEATH.| UNK_NGEN PUMP.| UNK_SOUNDSTAR ECO.