BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER

    MDR report key: 11635164 · Received April 8, 2021

    Report

    Report Number
    2134265-2021-04525
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER WAS USED IN A ATRIAL FIBRILLATION ABLATION PROCEDURE. WHEN HEMOSTASIS WAS PERFORMED SLIGHTLY LOW BLOOD PRESSURE WAS NOTED AND PERICARDIAL FLUID WAS SLIGHTLY ACCUMULATED. THIS WAS CONFIRMED WITH ECHOCARDIOGRAPHY.A PERICARDIAL DRAIN WAS PERFORMED. IT WAS NOTED THAT BRADYCARDIA CONTINUED AFTER THE ATRIAL FIBRILLATION WAS STOPPED. THE PATIENT THEN HAD A NON-BOSTON SCIENTIFIC PACEMAKER IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536195 INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 87047 0026218984

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention