BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 MM GARRETT VASCULAR DILATOR

    MDR report key: 25161753 · Received May 13, 2026

    Report

    Report Number
    MW5188133
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SONTEC INSTRUMENTS, INC.
    Product Code
    DWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 1.5MM CORONARY DILATOR BROKE WHEN ADJUSTING POSITION OF DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448280 1.5 MM GARRETT VASCULAR DILATOR DILATOR, VESSEL, SURGICAL DWP SONTEC INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1