BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEBRA

    MDR report key: 23989749 · Received January 7, 2026

    Report

    Report Number
    23989749
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    October 8, 2025
    Report Date
    November 7, 2025
    Manufacturer
    Q'APEL MEDICAL, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A VASCULAR CATHETER WAS THREADED THROUGH AN AORTIC STENT, AND THE CATHETER TIP WAS SHEARED OFF AND RETAINED WITHIN STENT AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49206 ZEBRA CATHETER, PERCUTANEOUS DQY Q'APEL MEDICAL, INC AC6074-095-30 FG250806C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other