BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION?

    MDR report key: 24220566 · Received January 30, 2026

    Report

    Report Number
    2124215-2026-05441
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. G4: K143481, K192360, K220796; REPORTED HERE AS THE PREMARKET / 510(K) # EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CEREBRAL INFARCTION. VENTRICULAR TACHYCARDIA (VT), VENTRICULAR FIBRILLATION (VF), ST SEGMENT ELEVATION, PERICARDIAL EFFUSION, AND TISSUE DAMAGE. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PERSISTENT ATRIAL FIBRILLATION AN INTELLAMAP ORION CATHETER WAS USED. PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ISOLATION TOOK PLACE WITH THE CATHETER. DURING THE FINAL STAGE OF THE POSTERIOR WALL ISOLATION AN ST SEGMENT ELEVATION WAS OBSERVED ON THE ELECTROCARDIOGRAM (ECG) AFTER DELIVERING A PULSE NEAR THE BOTTOM OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV). VT (VF) DEVELOPED AFTER THE ST ELEVATION. EXTERNAL DEFIBRILLATION WAS PERFORMED WHICH RESTORED SINUS RHYTHM. ADMINISTRATION OF MEDICATION AND CORONARY ANGIOGRAPHY (CAG) FOLLOWED THE DEFIBRILLATION. THERE APPEARED TO BE NO SIGNIFICANT OCCLUSIONS OR SPASMS NOTED IN THE CORONARY ARTERIES. A PERICARDIAL EFFUSION WAS DISCOVERED VIA ECHOCARDIOGRAPHY FROM THE SURFACE OF THE BODY. THE ECG CHANGES GRADUALLY RETURNED TO NORMAL, AND THE ST SEGMENT ELEVATION STABILIZED. THE PROCEDURE WAS COMPLETED, THEN THE PATIENT WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN WHICH REVEALED A CEREBRAL INFARCTION. AFTER THE PROCEDURE THE PHYSICIAN EXPRESSED CONCERN THAT TISSUE MAY HAVE BEEN SCRAPED AWAY WITHIN THE HEART OR LEFT ATRIAL APPENDAGE WHEN THE ORION MAPPING CATHETER WAS IN USE. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285740 INTELLAMAP ORION? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0037675194 08714729841968

    Patients

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