BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELUDE IDEAL HYDROPHILIC SHEATH

    MDR report key: 11700336 · Received April 21, 2021

    Report

    Report Number
    11700336
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 12, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    OEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SHEATH UNRAVELED IN THE PATIENT'S ARM AND I WAS UNABLE TO REMOVE THE SHEATH. SHEATH WAS EVENTUALLY ABLE TO BE COMPLETELY REMOVED. RESULTED IN A SMALL HEMATOMA, EVALUATED BY VASCULAR SURGERY. NO LASTING INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598581 PRELUDE IDEAL HYDROPHILIC SHEATH CARDIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX MERIT MEDICAL SYSTEMS, INC. 00884450532768

    Patients

    Seq Age Sex Outcome Treatment
    1 Other