BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLANAV STABLEPOINT OPEN-IRRIGATED

    MDR report key: 25164366 · Received May 13, 2026

    Report

    Report Number
    2124215-2026-25935
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    October 1, 2022
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FEICKERT S, D ANCONA G, BIERNATH K, BOEHMER AA, INCE H, ORTAK J, EWERTSEN NC. PULSED FIELD VS RADIOFREQUENCY ABLATION FOR POSTERIOR WALL ISOLATION IN PERSISTENT ATRIAL FIBRILLATION: A PROPENSITY MATCHED OUTCOME ANALYSIS. HEART RHYTHM O2. 2026 JAN 10;7(3):472 TO 477. DOI: 10.1016/J.HROO.2025.12.023. PMID: 41908182; PMCID: PMC13031013. B3 DATE OF EVENT: STUDY COMMENCEMENT DATE USED AS NO EVENT DATE WAS PROVIDED. THIS EVENT WAS REPORTED VIA A LITERATURE ARTICLE, THEREFORE DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. THIS EVENT WAS REPORTED VIA A LITERATURE ARTICLE AND IT IS UNLIKELY THE DEVICE WILL 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 VIA LITERATURE THAT A PERICARDIAL EFFUSION OCCURRED. A SINGLE CENTER, RETROSPECTIVE STUDY WAS PERFORMED BETWEEN OCTOBER 2022 TO JUNE 2024 ON NINETY-TWO (92) PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION. THE STUDY AIMED TO EVALUATE THE PROCEDURAL DIFFERENCES BETWEEN PULSE FIELD ABLATION (PFA) AND RADIOFREQUENCY (RF) ABLATION DURING LEFT ATRIAL POSTERIOR WALL ISOLATION. THE 92 PATIENTS WERE SPLIT EVENLY WITH FORTY-SIX (46) RECEIVING PFA AND 46 RECEIVING RF ABLATION. DURING THE RF ABLATION PROCEDURE A FLUOROSCOPY AND PRESSURE GUIDED SINGLE TRANSEPTAL PUNCTURE WITH A NON-BOSTON SCIENTIFIC (BSC) TRANSEPTAL NEEDLE WAS PERFORMED. INTRAVENOUS UNFRACTIONATED HEPARIN WAS ADMINISTERED TARGETING AN ACTIVATED CLOTTING TIME GREAT THAN 300 SECONDS. A NON BSC SHEATH WAS PLACED AND A STABLEPOINT CATHETER WAS ADVANCED TO THE LEFT ATRIUM. ABLATION WAS PERFORMED USING A POINT BY POINT, HIGH POWER, SHORT DURATION PROTOCOL OF 50W FOR TEN (10) SECONDS. LEFT ATRIAL POSTERIOR WALL ISOLATION WAS ACHIEVED BY CREATING A ROOF LINE BETWEEN THE SUPERIOR PULMONARY VEINS AND A POSTERIOR FLOOR LINE BETWEEN THE INFERIOR PULMONARY VEINS. ALL RF PROCEDURES WERE SUCCESSFULLY COMPLETED. OF THE 46 PATIENTS THAT UNDERWENT RF ABLATION USING THE STABLEPOINT CATHETER, ONE (1) EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED PERCUTANEOUS DRAINAGE. NO FURTHER INFORMATION ON THE STATUS OF THE PATIENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225727 INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1