BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRELUDEPRO SHEATH INTRODUCER

    MDR report key: 16714212 · Received April 10, 2023

    Report

    Report Number
    MW5116513
    Event Type
    Other
    Date Received
    April 10, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 7, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRITE TIP FROM VASCULAR SHEATH BECAME SEPARATED FROM SHEATH BODY. TIP WAS ABLE TO BE RETRIEVED FROM PATIENT'S A/V GRAFT. NO IMMEDIATE HARM OCCURRED TO PATIENT. VENDOR NOTIFIED, REMAINING LOT #S ISOLATED. SHEATH AND TIP BAGGED AND KEPT FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852563 PRELUDEPRO SHEATH INTRODUCER DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE MERIT MEDICAL SYSTEMS, INC. H2573764

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female