BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 25126004 · Received May 8, 2026

    Report

    Report Number
    2029046-2026-01521
    Event Type
    Death
    Date Received
    May 8, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC(PREMATURE VENTRICULAR CONTRACTION) / VT (VENTRICULAR TACHYCARDIA) REDO ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED HEART FAILURE THAT RESULTED IN DEATH. THE FIRST PROCEDURE SUCCESSFULLY COMPLETED MONDAY, (B)(6) 2026. AFTER FIRST PROCEDURE THE PATIENT WENT INTO INCESSANT VT AND WAS BROUGHT BACK TO EP (ELECTROPHYSIOLOGY) LAB FOR PROCEDURE ON (B)(6) 2026. AT PROCEDURE START THE PATIENT HAD INCESSANT VT AND PVC BEATS. OPTRELL MAPPING CATHETER WAS USED TO MAP SUBSTRATE DURING PACED RHYTHM AND VT/PVC MAP FOR DIFFERENT MORPHOLOGIES USING PARALLEL MAPPING. ABLATION WAS THEN PERFORMED WITH QDOT CATHETER USING QMODE ONLY ON LEFT AND RIGHT VENTRICLE IN SEPTAL POSITION (NO TRANSSEPTAL DONE, RETROGRADE APPROACH). PVC/VT BEATS WERE SUCCESSFULLY SUPPRESSED AT PROCEDURE END. CASE WAS SUCCESSFULLY COMPLETED AND PATIENT TRANSFERRED TO ICU (INTENSIVE CARE UNIT). THE NEXT MORNING, (B)(6) AROUND 01:00AM THE PATIENT DIED. THERE WERE NO COMPLICATIONS, STEAM POPS, TEMPERATURE OR IMPEDANCE SPIKES SEEN DURING THE CASE. PATIENT WAS NOT CARDIOVERTED DURING THE PROCEDURE. THE PHYSICIAN CONFIRMED THAT ADVERSE EVENT NOT RELATED TO EP ABLATION PROCEDURE. THE PATIENT WAS SICK; THE HEART MUSCLE WAS NOT HEALTHY AND PATIENT HAD ICD (IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR). FURTHERMORE, THE PATIENT HAD VARIOUS OTHER SYMPTOMS AND CONDITIONS INCLUDING BACTERIAL INFECTION AND DIARRHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573559 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31829365L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| D