BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARXFIT

    MDR report key: 20089193 · Received August 28, 2024

    Report

    Report Number
    2124215-2024-53876
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
    Product Code
    OAE
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT EXPERIENCED PHRENIC NERVE PARALYSIS.DURING A CRYO PROCEDURE OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), THE DIAPHRAGM MOVEMENT SENSOR (DMS)% DECREASED, WHEN THE DOCTOR CHECKED THE MOVEMENT OF THE PHRENIC NERVE, IT WAS WEAK, SO COOLING WAS STOPPED. THE TIMING OF STOPPING COOLING WAS 44 SECONDS, AT -50C. NO ADDITIONAL COOLING WAS PERFORMED TO THE RSPV, AND THE OTHER PVS WERE TREATED TO COMPLETE THE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197889 POLARXFIT CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC DE COSTA RICA S.R.L. 0033546366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown