BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 23562925 · Received November 14, 2025

    Report

    Report Number
    2029046-2025-03815
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 22, 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

    A PATIENT UNDERWENT A REDO ATRIAL FIBRILLATION (AFIB) WITH ALCOHOL ABLATION FOR PREMATURE VENTRICULAR CONTRACTION WITH A VARIPULSE CATHETER AND A QDOT CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. DEVICE EVALUATION 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31689064L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # PC-(B)(4).

    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).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A REDO ATRIAL FIBRILLATION (AFIB) WITH ALCOHOL ABLATION FOR PREMATURE VENTRICULAR CONTRACTION WITH A VARIPULSE CATHETER AND A QDOT CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED AFTER THE PULMONARY VEINS WERE ABLATED WITH A VARIPULSE CATHETER AND QDOT CATHETER, THE PHYSICIAN WAS MOVING FORWARD WITH AN ALCOHOL ABLATION OF A PREMATURE VENTRICULAR CONTRACTION (PVC). THEN, THEY SAW A PERICARDIAL EFFUSION ON THE INTRACARDIAC ECHO CATHETER. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS, BUT UNSURE OF HOW MUCH FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS IN STABLE CONDITION. 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
    2829971 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31689064L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L 8.5 FR VARIPULSE CATHETER.| CARTO 3.| NGEN.| TRUPULSE.