BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARADRIVE STEERABLE SHEATH

    MDR report key: 24569168 · Received March 11, 2026

    Report

    Report Number
    2124215-2026-13509
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    October 17, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    ARTICLE TITLE: ST-SEGMENT ELEVATION DURING TRANSSEPTAL PUNCTURE: A CASE REPORT OF A SEVERE PROCEDURAL COMPLICATION. ARTICLE CITATION: VAN DER GRAAF, M., BAX, I. N., RENSING, B. J. M. W., BALT, J. C., & BOERSMA, L. V. A. (2026). ST-SEGMENT ELEVATION DURING TRANSSEPTAL PUNCTURE: A CASE REPORT OF A SEVERE PROCEDURAL COMPLICATION. HEARTRHYTHM CASE REPORTS, 12(1), 20-23. HTTPS://DOI.ORG/10.1016/J.HRCR.2025.10.015. PER LITERATURE REVIEW, A 61-YEAR-OLD MALE PATIENT, KNOWN WITH SYMPTOMATIC PERSISTENT AF, WAS SCHEDULED FOR AN ELECTIVE PULMONARY VEIN ISOLATION PROCEDURE. EXCEPT FOR A KNOWN HISTORY OF HYPERTENSION, RECOVERED TACHYCARDIOMYOPATHY, AND LEFT BUNDLE BRANCH BLOCK, THE PATIENT'S MEDICAL HISTORY WAS UNREMARKABLE. PRE-PROCEDURAL ECHOCARDIOGRAPHY SHOWED A NORMAL EJECTION FRACTION, MILD MITRAL REGURGITATION, AND A NONDILATED LA (LA VOLUME INDEX 28 ML/M 2 ). PREPROCEDURAL MAGNETIC RESONANCE IMAGING WAS PERFORMED, SHOWING NO ANATOMICAL ABNORMALITIES. THE ABLATION PROCEDURE WAS PLANNED USING PULSED FIELD ABLATION TECHNOLOGY AND PERFORMED UNDER GENERAL ANESTHESIA WITH INTRAVENOUS PROPOFOL, FENTANYL, AND ROCURONIUM. AFTER A SUCCESSFUL TSP USING A RADIOFREQUENCY TRANSSEPTAL NEEDLE (NRG C1 RF) INTRAVENOUS HEPARIN AND ATROPINE WERE ADMINISTRATED. A CIRCULAR MAPPING CATHETER WAS INTRODUCED INTO THE LA THROUGH THE FARADRIVE SHEATH TO GUIDE ABLATION. ACCORDING TO THE INSTRUCTIONS FOR USE, THE SHEATH WAS CONNECTED TO A FLUSH LINE AND CONTINUOUSLY PERFUSED THROUGHOUT THE PROCEDURE. DURING LA MAPPING, A MARKED DROP IN BLOOD PRESSURE WAS OBSERVED, ACCOMPANIED BY WIDESPREAD ST-SEGMENT DEVIATIONS ACROSS ALL ELECTROCARDIOGRAM (ECG) LEADS, SHORTLY FOLLOWED BY CARDIAC ARREST. DURING RESUSCITATION, ALTERNATING EPISODES OF VENTRICULAR FIBRILLATION AND PULSELESS ELECTRICAL ACTIVITY WERE OBSERVED. ADRENALINE AND AMIODARONE WERE ADMINISTERED ACCORDING TO THE RESUSCITATION PROTOCOL. TRANSTHORACIC ULTRASOUND WAS PERFORMED TO EXCLUDE TAMPONADE AND PERICARDIAL EFFUSION. URGENT CORONARY ANGIOGRAPHY (CAG) SHOWED NO SIGNS OF EITHER CORONARY ARTERY DISEASE OR AIR EMBOLISM (FIGURE 1C AND 1D). AFTER RECOVERY OF CARDIAC OUTPUT AND NORMALIZATION OF THE ECG, THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. POSTOPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A REDUCED LEFT VENTRICULAR EJECTION FRACTION (45%-49%) WITH APICOSEPTAL HYPOKINESIS, WHILE LABORATORY RESULTS DEMONSTRATED MILDLY ELEVATED TROPONIN AND CREATINE KINASE LEVELS. THE MOST LIKELY CAUSE OF THIS INCIDENT WAS CONSIDERED TO BE AIR EMBOLISM TO THE RIGHT CORONARY ARTERY, PRESUMED TO HAVE OCCURRED DURING THE INTRODUCTION OF THE MAPPING CATHETER. 4 THE PATIENT MADE A RAPID RECOVERY AND WAS DISCHARGED FROM THE HOSPITAL WITHIN A FEW DAYS, WITHOUT ANY SIGNS OF NEUROLOGICAL DAMAGE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627049 FARADRIVE STEERABLE SHEATH CATHETER, STEERABLE DRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R