BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV STABLEPOINT OPEN-IRRIGATED

    MDR report key: 15941214 · Received December 8, 2022

    Report

    Report Number
    2124215-2022-49905
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 19, 2022
    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, 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 DEVICE LUMEN WAS LEAK TESTED USING AN ISAAC HD LEAK TESTER (PRESSURE DECAY TEST SYSTEM) AND A TOUHY BOURST SEAL FOR SEALING THE IRRIGATION HOLES. THE LUMEN PRESSURE DECAY WAS MEASURED THREE TIMES. THE UNIT PASSED THE TEST WITHOUT PROBLEMS. THEN, A FLOW TEST WAS PERFORMED CONNECTING THE DEVICE TO A METRIQ PUMP AND WAS PURGED. ALL SIX IRRIGATION PORTS FLOW FREELY. THE PUMP WAS PROGRAMMED TO AND THE DEVICE WAS IRRIGATED FOR 5 MINUTES WITHOUT ANY ERRORS OR PUMP MESSAGES. FINALLY, AN ELECTRICAL TEST AND A RF ABLATION TEST WERE CONDUCTED, AND THE ABLATION WAS VERIFIED BY USING THE MAESTRO GENERATOR 4000 AND METRIQ PUMP, AND THE DEVICE WAS FOUND WITHIN SPECIFICATIONS. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. CATHETER 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 A PERCUTANEOUS MYOCARDIAL ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION ON THE LEFT ATRIUM, AN INTELLANAV STABLEPOINT OPEN IRRIGATED CATHETER WAS SELECTED FOR USE. FLOW RATE USED WAS 60ML/MIN. FLUSHING OUTSIDE THE BODY CONFIRMED OCCLUSION OF THE IRRIGATION PORT, THEREFORE IRRIGATION FLOW WAS INSUFFICIENT. 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 HAS BEEN RECEIVED BY BOSTON SCIENTIFIC CORPORATION FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION A PERCUTANEOUS MYOCARDIAL ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION ON THE LEFT ATRIUM, AN INTELLANAV STABLEPOINT OPEN IRRIGATED CATHETER WAS SELECTED FOR USE. FLOW RATE USED WAS 60ML/MIN. FLUSHING OUTSIDE THE BODY CONFIRMED OCCLUSION OF THE IRRIGATION PORT, THEREFORE IRRIGATION FLOW WAS INSUFFICIENT. 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
    448961 INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC CORPORATION 0029428121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown