BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRELUDE SHEATH INTRODUCER

    MDR report key: 25159054 · Received May 12, 2026

    Report

    Report Number
    MW5188095
    Event Type
    Injury
    Date Received
    May 12, 2026
    Report Date
    February 23, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    OEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PSEUDOANEURYSM. AFTER A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARADRIVE SHEATH IT WAS DISCOVERED THE PATIENT HAD A PSEUDOANEURYSM. AN UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49649 PRELUDE SHEATH INTRODUCER CARDIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention