BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFACE

    MDR report key: 25175102 · Received May 14, 2026

    Report

    Report Number
    2029046-2026-01574
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A PREFACE SHEATH AND THE PATIENT EXPERIENCED BLEEDING THAT REQUIRED HOSPITALIZATION. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY GAINING ACCESS WITH THE 10 FRENCH COOK SHEATH, AND AFTER THEY WENT TRANSEPTAL THEY NOTICED THE PATIENT BLOOD PRESSURE DROPPING. THEY ATTEMPTED TO ABLATE WITH THE FARAWAVE¿ PFA CATHETER, AND THE FARASTAR DISPLAYED AN ERROR, "ELECTRODES WERE TOO CLOSE", BUT THEY WERE NOT. THE CATHETER WAS PLACED IN BASKET, THEN FLOWER MODE AND IT WOULD ALLOW THEM TO ABLATE (NO ENERGY APPLIED SYSTEM AUTO SHUT OFF). THE CATHETER, CABLE AND FARASTAR WERE ALL REPLACED AND STILL WOULD NOT DELIVER ENERGY. THE CASE WAS ABORTED AND NO ABLATION WAS PERFORMED. THE PHYSICIAN STATED THE IVC (INFERIOR VENA CAVA) BLEED MAY HAVE CAUSED AN IMPEDANCE CHANGE IN THE HEART. THE PHYSICIAN NOTED AN IVC BLEED AS THE INJURY, DISCOVERED DUE TO THE DROP IN PRESSURE. THE INJURY WAS CONFIRMED BY UNKNOWN IMAGING. NO MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT, THEY DID NOT REQUIRE ANY SURGICAL REPAIR AND RECOVERED ON THEIR OWN. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION, PATIENT WAS ADMITTED TO CVICU (CARDIOVASCULAR INTENSIVE CARE UNIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378547 PREFACE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L