BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE STEERABLE SHEATH

    MDR report key: 25164134 · Received May 13, 2026

    Report

    Report Number
    2124215-2026-25932
    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
    DRA
    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 VASCULAR COMPLICATIONS AND AN AIR EMBOLISM 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 PFA 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 FARADRIVE STEERABLE SHEATH WAS PLACED AND A 31MM FARAWAVE CATHETER WAS ADVANCED TO THE LEFT ATRIUM. EACH PULMONARY VEIN WAS TREATED WITH FOUR (4) APPLICATIONS OF ABLATION IN BOTH BASKET AND FLOWER CONFIGURATIONS. LEFT ATRIAL POSTERIOR WALL ISOLATION WAS ACHIEVED USING OVERLAPPING APPLICATIONS IN THE FLOWER CONFIGURATION, WITH LATERAL AND SEPTAL ANCHORING LESIONS DELIVERED VIA PLACEMENT OF THE UNKNOWN GUIDEWIRE INTO THE ADJACENT PULMONARY VEINS. ALL PFA PROCEDURES WERE SUCCESSFULLY COMPLETED. OF THE 46 PATIENTS THAT UNDERWENT PFA ABLATION USING THE FARADRVE STEERABLE SHEATH ONE (1) EXPERIENCED A CORONARY AIR EMBOLISM WITHOUT LASTING CLINICAL CONSEQUENCES. TWO (2) PATIENTS EXPERIENCED ACCESS SITE VASCULAR COMPLICATIONS. NO FURTHER INFORMATION ON THE STATUS OF THE PATIENTS IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306898 FARADRIVE STEERABLE SHEATH CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other