BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARX

    MDR report key: 21842681 · Received April 15, 2025

    Report

    Report Number
    2124215-2025-23552
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. A GOOD FAITH EFFORT IS UNABLE TO BE PERFORMED TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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 VIA VOLUNTARY MEDWATCH MW5168304 THAT THE PATIENT EXPERIENCED PHRENIC NERVE INJURY. DURING A CRYO ABLATION PROCEDURE A POLARX CATHETER WAS SELECTED FOR USE. WHILE ABLATING THE RIGHT INFERIOR PULMONARY VEIN (RIPV), A PHRENIC NERVE INJURY (PNI) OCCURRED. THE ABLATION WAS TERMINATED AFTER TWO SECONDS OF LOSS. THE PNI DID NOT RECOVER AFTER TEN MINUTES WAITING. THE CASE WAS ABORTED, AND THE RIPV WAS NOT ISOLATED. ALL TARGETED PULMONARY VEINS WERE ISOLATED. IT IS UNKNOWN IF THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT IS UNKNOWN IF THE PNI RECOVERED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED A DAY LATER. THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. THERE WAS NO INDICATION THAT THE DEVICE IS AVAILABLE FOR RETURN. GOOD FAITH EFFORT (GFE) IS NOT POSSIBLE AS THE EVENT WAS REPORTED DIRECTLY BY THE FDA WITH NO REPORTER OR FACILITY INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126789 POLARX CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC DE COSTA RICA S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization