BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV STABLEPOINT OPEN-IRRIGATED

    MDR report key: 16380227 · Received February 15, 2023

    Report

    Report Number
    2124215-2023-05540
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER WAS EVALUATED BY BOSTON SCIENTIFIC CORPORATION. VISUAL INSPECTION NOTED THAT THE CATHETER SHAFT WAS DAMAGED AT DISTAL SECTION. A FUNCTIONAL TEST WAS PERFORMED AND THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. LEAKAGE TEST WAS DONE; THE LUMEN OF THE DEVICE WAS LEAK TESTED USING AN ISAAC HD LEAK TESTER (PRESSURE DECAY TEST SYSTEM) AND A TOUHY BOURST SEAL FOR SEALING THE IRRIGATION HOLES AND MINI ELECTRODES. THE LUMEN PRESSURE DECAY WAS MEASURED THREE TIMES. THE UNIT PASSED THE TEST WITHOUT PROBLEMS. FINALLY, A FLOW TEST WAS CONDUCTED; THE DEVICE WAS CONNECTED TO A METRIQ PUMP AND WAS PURGED AT 60 ML/MIN. ALL SIX IRRIGATION PORTS FLOW FREELY. THE PUMP WAS PROGRAMMED TO 30ML/MIN AND THE DEVICE WAS IRRIGATED FOR 5 MINUTES WITHOUT ANY ERRORS OR PUMP MESSAGES. THE DEVICE WAS FOUND WITHIN SPECIFICATIONS. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL TACHYCARDIA, AN INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. FLOW RATE WAS 60ML/MIN. AN INSUFFICIENT IRRIGATION AMOUNT WHEN FLUSHING WAS PERFORMED AS USUAL. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290225 INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC CORPORATION 0029560820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown