BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLAMAP ORION?

    MDR report key: 24759996 · Received April 1, 2026

    Report

    Report Number
    2124215-2026-18021
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    PMA / PMN Number
    K143481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K192360, K220796. INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED ALLEGATION OF CATHETER STUCK IN ARTICULATED POSITION WAS NOT CONFIRMED. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS OF RETURNED PRODUCT REVEALED THAT THE DEVICE SHOWED NO EVIDENCE OR DEFECTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. FUNCTIONAL TESTING SHOWED THAT THE CATHETER FUNCTIONAL MECHANISM WORKED PROPERLY. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE DEVICE. DEVICE HISTORY RECORD REVIEW THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. LABELING REVIEW BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. RISK REVIEW A REVIEW OF THE INTELLAMAP ORION CATHETER DEVICE HAZARD ANALYSIS WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STUCK IN ARTICULATED POSITION" 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: BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "NO PROBLEM DETECTED". THE INVESTIGATIONS FINDINGS CLEARLY CONFIRM THAT THERE WAS NO PROBLEM WITH THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION ON THE LEFT ATRIUM, AN INTELLAMAP ORION CATHETER WAS SELECTED FOR USE. FLEXION FAILURE HAS OCCURRED DURING THE MAPPING OF RIGHT ATRIUM WITH ORION. UPON REMOVAL FROM THE BODY FOR INSPECTION, IT REMAINED BENT DESPITE THE HANDLE BEING IN THE NEUTRAL POSITION. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION ON THE LEFT ATRIUM, AN INTELLAMAP ORION CATHETER WAS SELECTED FOR USE. FLEXION FAILURE HAS OCCURRED DURING THE MAPPING OF RIGHT ATRIUM WITH ORION. UPON REMOVAL FROM THE BODY FOR INSPECTION, IT REMAINED STUCK IN THE ARTICULATED POSITION DESPITE THE HANDLE BEING IN THE NEUTRAL POSITION. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542097 INTELLAMAP ORION? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0038308047 08714729841968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown