BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLAMAP ORION

    MDR report key: 20919987 · Received December 12, 2024

    Report

    Report Number
    2124215-2024-78834
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 26, 2024
    Report Date
    April 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    PMA / PMN Number
    K143481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INTELLAMAP ORION CATHETER WAS EVALUATED BY BOSTON SCIENTIFIC. UPON RECEIPT AT THE POST MARKET LABORATORY, IT WAS NOTED THAT THE DEVICE HAS ONE SPLINE DETACHED AND ALSO DE SHAFT CUTTED, CONSEQUENTLY CONFIRMING THE REPORTED CLINICAL OBSERVATIONS OF ARRAY DAMAGED/DEFECTIVE AND CATHETER DIFFICULT TO WITHDRAW. PREMARKET / 510(K) # K143481, K192360, K220796.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND CATHETER ARRAY DAMAGE OCCURRED. IT WAS REPORTED THAT DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) PROCEDURE, AN INTELLAMAP ORION CATHETER WAS USED. IT WAS NOTED THAT THE ORION CATHETER GOT STUCK WITH A QUADRIPOLAR DIAGNOSTIC CATHETER. NO RESISTANCE WAS FELT PRIOR TO THE CATHETER GETTING ENTANGLED. AFTER THE TWO WERE UNTANGLED, THE ORION WAS REMOVED, AND IT WAS NOTED THAT ONE OF THE SPLINES OF THE ORION HAD DETACHED FROM THE DISTAL PART OF THE CATHETER. ONE OF THE SPLINES OF THE ORION HAD DETACHED FROM THE DISTAL PART OF THE CATHETER. THE PHYSICIAN COMMENTED ON THERE BEING A LOT OF COLLATERAL BRANCHES OF THE LOWER VEINS WHEN TRYING TO REACH THE HEARTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING A NEW ORION CATHETER. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND CATHETER ARRAY DAMAGE OCCURRED. IT WAS REPORTED THAT DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) PROCEDURE, AN INTELLAMAP ORION CATHETER WAS USED. IT WAS NOTED THAT THE ORION CATHETER GOT STUCK WITH A QUADRIPOLAR DIAGNOSTIC CATHETER. NO RESISTANCE WAS FELT PRIOR TO THE CATHETER GETTING ENTANGLED. AFTER THE TWO WERE UNTANGLED, THE ORION WAS REMOVED, AND IT WAS NOTED THAT ONE OF THE SPLINES OF THE ORION HAD DETACHED FROM THE DISTAL PART OF THE CATHETER. ONE OF THE SPLINES OF THE ORION HAD DETACHED FROM THE DISTAL PART OF THE CATHETER. THE PHYSICIAN COMMENTED ON THERE BEING A LOT OF COLLATERAL BRANCHES OF THE LOWER VEINS WHEN TRYING TO REACH THE HEARTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING A NEW ORION CATHETER. THE DEVICE WAS RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417299 INTELLAMAP ORION CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0033052499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown