BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV STABLEPOINT OPEN-IRRIGATED

    MDR report key: 16253421 · Received January 27, 2023

    Report

    Report Number
    2124215-2023-02963
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 6, 2023
    Report Date
    March 2, 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 DID NOT NOTE ANY VISUAL DEFECTS ON THE DEVICE. 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 ON THE DEVICE LUMEN 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 PERFORMED WHILE 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. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. DEVICE WAS FOUND WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION OF A MYOCARDIAL ABLATION PROCEDURE, AN INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT WHEN THE IRRIGATION WAS FAST-FORWARDED DURING PREPARATION, THE FLOW WAS NOT COMING OUT OF ONE OF THE SIX HOLES. FLOW RATE WAS 60ML/MIN. NO ERROR MESSAGES WERE DISPLAYED. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION OF A MYOCARDIAL ABLATION PROCEDURE, AN INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT WHEN THE IRRIGATION WAS FAST-FORWARDED DURING PREPARATION, THE FLOW WAS NOT COMING OUT OF ONE OF THE SIX HOLES. FLOW RATE WAS 60ML/MIN. NO ERROR MESSAGES WERE DISPLAYED. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617518 INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC CORPORATION 0029339981

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown