BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 25104385 · Received May 6, 2026

    Report

    Report Number
    2029046-2026-01493
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 14, 2026
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED CARDIAC ARREST WHICH REQUIRED RESUSCITATION AND ATRIAL TACHYCARDIA WHICH REQUIRED CARDIOVERSION. AFTER THE PULMONARY VEIN ISOLATION, THEY WERE DOING THE POSTERIOR WALL ISOLATION, THEY WERE ABLATING THE SUPERIOR WALL AND THE PATIENT¿S BLOOD PRESSURE DROPPED. PULSE WAS CHECKED AND THERE WAS NO PULSE, THERE WAS ALSO NO HEARTBEAT ON THE INTRACARDIAC ULTRASOUND. THE PATIENT WAS ADMINISTERED WITH AN EPINEPHRINE, THEY STARTED COMPRESSIONS, AND AFTER FOUR COMPRESSIONS, THEY NOTICED THE HEART BEATING ON THE ULTRASOUND. THE PATIENT WAS IN AN ATRIAL TACHYCARDIA AND CARDIOVERTED BACK TO SINUS. ONCE THE PATIENT STABILIZED, THEY CONTINUED THE PROCEDURE AND COMPLETED THE POSTERIOR WALL ISOLATION. THE PATIENT HAD ISSUES MAINTAINING THEIR SATURATION. ONCE THE ABLATION WAS COMPLETED, THE PHYSICIAN CHECKED FOR AN EFFUSION, AND NONE WAS FOUND. THE HEART WAS UNCHANGED FROM THE BEGINNING OF THE CASE. THERE WERE ISSUES EXTUBATING THE PATIENT, BUT THEY WERE ABLE TO EXPEDITE AND PLACE PATIENT IN A NON-REBREATHER MASK. THE PATIENT¿S LAST KNOWN STATUS WAS TRANSFERRED TO INTENSIVE CARE UNIT AND STABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354608 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31779708L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1