BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE STEERABLE SHEATH

    MDR report key: 24583568 · Received March 12, 2026

    Report

    Report Number
    2124215-2026-13949
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE). IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A SEPARATED REPORT WILL BE SUBMITTED FOR THE FARADRIVE - SECOND CASE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. ARTICLE CITATION: TUBEK, S., BRZOZOWSKI, P., NIEWINSKI, P., TRZECIAK, D., PONIKOWSKI, P., & NOWAK, K. (2026, JANUARY 13). 3D GUIDED PULSED FIELD VERSUS RADIOFREQUENCY ABLATION AFTER A FAILED INITIAL PULMONARY VEIN ISOLATION IN THE TERTIARY POLISH CENTER. POLISH HEART JOURNAL (KARDIOLOGIA POLSKA). ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.33963/V.PHJ.110626.

    Description of Event or Problem · 0

    A CEREBRAL VASCULAR ACCIDENT, TRANSIENT ISCHEMIC ATTACK AND VISUAL DISTURBANCES OCCURRED. IT WAS REPORTED IN THE LITERATURE ARTICLE THAT 90 OF THESE PATIENTS UNDERWENT HIGH-DENSITY MAPPING-GUIDED ABLATION AND WERE INCLUDED IN THE ANALYSIS - 20 TREATED WITH 3D-GUIDED PFA AND 70 WITH RFA. STANDARDIZED PROCEDURAL PROTOCOLS, INCLUDING PERIPROCEDURAL ANTICOAGULATION REGIMEN WERE FOLLOWED. AFTER THE TRANSSEPTAL PUNCTURE SINUS RHYTHM WAS RESTORED WHENEVER ATRIAL FIBRILLATION WAS PRESENT WITH ELECTRICAL CARDIOVERSION. HIGH-DENSITY ELECTROANATOMICAL MAPPING WAS USED TO ASSESS PULMONARY VEIN RECONNECTION AND LOW-VOLTAGE AREAS. PULSED FIELD ABLATION WAS DELIVERED VIA THE STANDARD FARAWAVE 31 MM CATHETER WITH ELECTROANATOMICAL IMPEDANCE-BASED NAVIGATION. RADIOFREQUENCY ABLATION WAS PERFORMED. THE LESIONS SETS OUTSIDE OF THE PULMONARY VEINS (PV) WERE INDIVIDUALLY TAILORED ACCORDING TO IDENTIFIED SUBSTRATES. THE COMPLETENESS OF ALL ABLATION SITES WAS CONFIRMED WITH PACING MANOEUVRES AND RE-MAPPING. TWO STROKES OCCURRED IN THE PFA GROUP COMPARED TO NONE IN THE RFA GROUP; HOWEVER, NEUROLOGICAL SYMPTOMS IN BOTH CASES WERE TRANSIENT. IN THE FIRST CASE, THE PATIENT EXPERIENCED DIPLOPIA, WHICH RESOLVED WITHIN 48 HOURS; HOWEVER, A BRAIN MAGNETIC RESONANCE IMAGING SCAN SHOWED A SMALL (3-4 MM) ISCHEMIC LESION IN THE REGION OF THE SIXTH CRANIAL NERVE NUCLEUS. IN THE SECOND CASE, THE PATIENT REPORTED TRANSIENT PARESTHESIA OF THE LEFT LOWER LIMB, LASTING UP TO 72 HOURS POST-PROCEDURE. THE PATIENT HAD A HISTORY OF SIMILAR SYMPTOMS, WHICH HAD NOT BEEN PREVIOUSLY INVESTIGATED. A BRAIN COMPUTED TOMOGRAPHY PERFORMED WITHIN 24 HOURS OF SYMPTOM ONSET SHOWED NO ACUTE ISCHEMIC LESIONS, AND THE PATIENT DECLINED A FOLLOW-UP MAGNETIC RESONANCE IMAGING SCAN. INTRA-PROCEDURAL ACTIVATED CLOTTING TIME WAS 350 S IN BOTH CASES. TWO THROMBOEMBOLIC CEREBRAL EVENTS OCCURRED IN THE PFA GROUP, BOTH WITH TRANSIENT SYMPTOMS. THESE MAY HAVE RESULTED FROM THE CATHETER EXCHANGES THROUGH THE LARGE FARADRIVE 13F (BOSTON SCIENTIFIC, MARLBOROUGH, MA, US) SHEATH, CREATING A MISMATCH WITH THE SMALLER MAPPING CATHETER (8.5F) AND THUS BLOOD INGRESS INTO THE SHEATH DURING FURTHER MAPPING CATHETER MANIPULATION, PROMOTING MICROTHROMBUS FORMATION. ARTICLE CITATION: TUBEK, S., BRZOZOWSKI, P., NIEWINSKI, P., TRZECIAK, D., PONIKOWSKI, P., & NOWAK, K. (2026, JANUARY 13). 3D GUIDED PULSED FIELD VERSUS RADIOFREQUENCY ABLATION AFTER A FAILED INITIAL PULMONARY VEIN ISOLATION IN THE TERTIARY POLISH CENTER. POLISH HEART JOURNAL (KARDIOLOGIA POLSKA). ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.33963/V.PHJ.110626.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579095 FARADRIVE STEERABLE SHEATH CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1