BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION

    MDR report key: 25038303 · Received April 29, 2026

    Report

    Report Number
    2124215-2026-23356
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    PMA / PMN Number
    K143481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K192360, K220796. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PULMONARY VEIN ISOLATION PROCEDURE, AN INTELLAMAP ORION CATHETER WAS SELECTED FOR USE. 60 MINUTES INTO THE ORION MAPPING PROCEDURE, A DECREASE IN BLOOD PRESSURE WAS OBSERVED. THE BLOOD PRESSURE DID NOT RETURN TO NORMAL OVER TIME, AND IT WAS CONFIRMED THROUGH AN ECHOCARDIOGRAM THAT A PERICARDIAL EFFUSION OCCURRED, INDICATING A STATE OF CARDIAC TAMPONADE. PERICARDIOCENTESIS WITH DRAINAGE WAS PERFORMED AND THE SYMPTOMS IMPROVED. THE PATIENT WAS TRANSFERRED FROM THE GENERAL WARD TO THE HIGH CARE UNIT. THE PATIENT IS CURRENTLY NOT PRESENTING ANY WORSENING OF SYMPTOMS RELATED TO THE CARDIAC TAMPONADE. THE DEVICE WAS DISPOSED AND WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295430 INTELLAMAP ORION CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0038691826 08714729841968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R