BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARXFIT

    MDR report key: 20682844 · Received November 14, 2024

    Report

    Report Number
    2124215-2024-71065
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
    Product Code
    OAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT/PRODUCT PROBLEM FROM SERIOUS INJURY TO MALFUNCTION. OUTCOMES ATTRIB TO ADV EVENT FROM OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) TO NONE. TYPE OF REPORTABLE EVENT FROM SERIOUS INJURY TO MALFUNCTION. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE PALSY, AND THE PROCEDURE WAS DISCONTINUED. DURING A CRYOABLATION PROCEDURE, A POLARX FIT BALLOON CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT POLARX WAS USED TO TREAT THE LEFT SUPERIOR PULMONARY VEIN, LEFT INFERIOR PULMONARY VEIN, RIGHT INFERIOR PULMONARY VEIN AND RIGHT SUPERIOR PULMONARY VEIN. THE PHRENIC NERVE STOPPED RESPONDING DURING RIGHT SUPERIOR PULMONARY VEIN COOLING. THE MINIMUM COOLING TEMPERATURE WAS -61DEGREES CELSIUS WITH A TTI OF 25 SECONDS, AND THE W STOPPED AFTER 102 SECONDS OF COOLING. DUE TO THE STATE IF PHRENIC NERVE DAMAGE, THE PHYSICIAN CHOSE TO DISCONTINUE TREATMENT; NO ADDITIONAL COOLING OF THE RIGHT SUPERIOR VEIN OR ROOF ABLATIONS WERE PERFORMED. DURING COOLING, THE DOCTOR PERFORMED PALPATION, C-MAP MONITORING, AND DMS MONITORING, BUT THERE WERE FLUCTUATIONS IN THE INTENSITY OF PALPATION, AND IT SEEMS THAT C-MAP MONITORING WAS NOT PERFORMED CONTINUOUSLY. NO MEDICAL SURGICAL INTERVENTION WAS REQUIRED. IT WAS CONFIRMED BY CONTRAST THAT IT WAS AN OBSTRUCTION AT THE ANTRUM. THE NERVE PALSY RECOVERED BY THE END OF THIS TREATMENT. THE DEVICE HAS BEEN DISCARDED AND IS UNAVAILABLE FOR RETURN ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS DISCONTINUED. DURING A CRYOABLATION PROCEDURE, A POLARX FIT BALLOON CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT POLARX WAS USED TO TREAT THE LEFT SUPERIOR PULMONARY VEIN, LEFT INFERIOR PULMONARY VEIN, RIGHT INFERIOR PULMONARY VEIN AND RIGHT SUPERIOR PULMONARY VEIN. THE PHRENIC NERVE STOPPED RESPONDING DURING RIGHT SUPERIOR PULMONARY VEIN COOLING. THE MINIMUM COOLING TEMPERATURE WAS -61DEGREES CELSIUS WITH A TTI OF 25 SECONDS, AND THE W STOPPED AFTER 102 SECONDS OF COOLING. DUE TO THE STATE IF PHRENIC NERVE DAMAGE, THE PHYSICIAN CHOSE TO DISCONTINUE TREATMENT; NO ADDITIONAL COOLING OF THE RIGHT SUPERIOR VEIN OR ROOF ABLATIONS WERE PERFORMED. DURING COOLING, THE DOCTOR PERFORMED PALPATION, C-MAP MONITORING, AND DMS MONITORING, BUT THERE WERE FLUCTUATIONS IN THE INTENSITY OF PALPATION, AND IT SEEMS THAT C-MAP MONITORING WAS NOT PERFORMED CONTINUOUSLY. NO MEDICAL SURGICAL INTERVENTION WAS REQUIRED. IT WAS CONFIRMED BY CONTRAST THAT IT WAS AN OBSTRUCTION AT THE ANTRUM. THE NERVE PALSY RECOVERED BY THE END OF THIS TREATMENT. THE DEVICE HAS BEEN DISCARDED AND IS UNAVAILABLE FOR RETURN ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168662 POLARXFIT CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC DE COSTA RICA S.R.L. 0034487746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other