BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION?

    MDR report key: 24457250 · Received February 26, 2026

    Report

    Report Number
    2124215-2026-10748
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 20, 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) #'S EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, ALTHOUGH NO PRODUCT HAS BEEN RETURNED DUE TO DISPOSAL, WE HAVE DETERMINED THAT THE CARDIAC TAMPONADE IS A KNOWN INHERENT RISK WITH USE OF THIS PRODUCT. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. DEVICE TECHNICAL ANALYSIS: IT WAS INDICATED THE DEVICE IS UNAVAILABLE FOR RETURN; THEREFORE, A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE CONFIRMED THAT CARDIAC TAMPONADE IS ADDRESSED AS A POTENTIAL PROCEDURAL COMPLICATION WHEN USING THE INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER. ADDITIONALLY, BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS/INSTRUCTIONS FOR USE. RISK REVIEW: A REVIEW OF THE INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER RISK DOCUMENTATION WAS COMPLETED AND CONFIRMED THAT THE EVENT OF CARDIAC TAMPONADE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED EVENT OF CARDIAC TAMPONADE IS A KNOWN INHERENT RISK OF THE INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER. AS STATED BY THE INSTRUCTIONS FOR USE, "POTENTIAL ADVERSE EVENTS RELATED TO THE MAPPING, THE ABLATION CATHETER(S), AND/OR THE INTERVENTIONAL PROCEDURE INCLUDE, BUT ARE NOT LIMITED TO: CARDIAC TRAUMA, FOR EXAMPLE: CARDIAC TAMPONADE." THERE WERE NO INDICATIONS THAT THE DEVICE WAS USED OUTSIDE THE BOUNDS OF LABELED/INDICATED USE OR EVIDENCE OF A PRODUCT PERFORMANCE RELATED ISSUE. G4: K143481, K192360, K220796 (REPORTED HERE AS THE PREMARKET / 510(K) #'S EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE. AFTER AN ABLATION PROCEDURE USING AN INTELLAMAP ORION CATHETER THE PATIENT EXPERIENCED CARDIAC TAMPONADE SHORTLY AFTER RETURNING TO THE HOSPITAL WARD. THE COMPLICATION WENT UNNOTICED ON THE DAY OF THE PROCEDURE AS THE PATIENT'S BLOOD PRESSURE REMAINED STABLE, BUT IT WAS OBSERVED ON ECHOCARDIOGRAM THE FOLLOWING DAY. THE PATIENT HAD A THORACOTOMY PERFORMED SIX DAYS AFTER THE PROCEDURE. THE TAMPONADE LIKELY OCCURRED AROUND THE LEFT INFERIOR (LI) OF THE LEFT ATRIUM (LA). THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE. AFTER AN ABLATION PROCEDURE USING AN INTELLAMAP ORION CATHETER THE PATIENT EXPERIENCED CARDIAC TAMPONADE SHORTLY AFTER RETURNING TO THE HOSPITAL WARD. THE COMPLICATION WENT UNNOTICED ON THE DAY OF THE PROCEDURE AS THE PATIENT'S BLOOD PRESSURE REMAINED STABLE, BUT IT WAS OBSERVED ON ECHOCARDIOGRAM THE FOLLOWING DAY. THE PATIENT HAD A THORACOTOMY PERFORMED SIX DAYS AFTER THE PROCEDURE. THE TAMPONADE LIKELY OCCURRED AROUND THE LEFT INFERIOR (LI) OF THE LEFT ATRIUM (LA). THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144364 INTELLAMAP ORION? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0037991971 08714729841968

    Patients

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