BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 24448775 · Received February 25, 2026

    Report

    Report Number
    2029046-2026-00647
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    January 30, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH TWO (2) QDOT MICTRO CATHETERS AND THE PATIENT DISSOCIATED ON A VT EPISODE TREATED WITH CARDIOPULMONARY RESUSCITATION, IMPLEMENTATION OF ECMO AND PROLONGED HOSPITALIZATION. THE PATIENT EXPERIENCED PATIENT DISSOCIATED ON A VT EPISODE TREATED WITH CARDIOPULMONARY RESUSCITATION AND IMPLEMENTATION OF ECMO. NO ABLATION WAS IN PROGRESS DURING THE INCIDENT. THE PATIENT RETURNED TO RESUSCITATION SERVICE FOR THE WEEKEND WITH NEURO SURVEILLANCE. THE PATIENT WAS TAKEN BACK ON TUESDAY, (B)(6) 2026 FOLLOWING MEDICAL DISCUSSION. NO PROBLEM WITH THE SECOND PROCEDURE, AND NO LINK BETWEEN THE INCIDENT AND THE EQUIPMENT USED. THE PATIENT WAS FRAIL AND SUFFERED FROM AORTIC DISSECTION WITH RECURRENT VT EPISODES. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, AND THEY STOPPED THE PROCEDURE. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE PATIENT SPENT TOO MUCH TIME IN VT. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF ECMO. THE FORCE SENSING ABLATION CATHETER USED WAS QDOT. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE VISITAG IN LEGACY MODE WITH THE USUAL PARAMETERS OF RESPIRATION GATED, 3MM, AND 3S. THE COLOR OPTION USED PROSPECTIVELY WAS ABLATION INDEX. AN NGEN GENERATOR WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511361 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31749850L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H CARTO3 EXTERNAL REFPATCH 6PACK| CARTO3 SYSTEM| NGEN