BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEBRA

    MDR report key: 24076640 · Received January 14, 2026

    Report

    Report Number
    3015614-2026-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 14, 2026
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    DQY
    UDI-DI
    00857545008219
    PMA / PMN Number
    K240746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING A RADIAL ACCESS PROCEDURE, THE PHYSICIAN OBSERVED BLOOD ESCAPING FROM THE HUB OF A ZEBRA CATHETER DURING USE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT FURTHER INCIDENT. A CUSTOMER-PROVIDED IMAGE TAKEN AT THE TIME OF THE EVENT SHOWED THE CATHETER INTACT IN ONE PIECE WITH A LOCALIZED SURFACE DISCONTINUITY (FRACTURE) JUST DISTAL TO THE STRAIN RELIEF. THE USER REPORTED THAT NO RESISTANCE OR TORQUING WAS ENCOUNTERED DURING USE. EVALUATION OF THE RETURNED DEVICE SHOWED THAT THE CATHETER WAS FRACTURED JUST DISTAL TO THE STRAIN RELIEF (1-2 MM), A LOCATION THAT EXPERIENCES ELEVATED MECHANICAL STRESS WHEN SUBJECTED TO TIGHT-RADIUS BENDING OR OFF-AXIS LOADING. NO EVIDENCE OF DESIGN OR MANUFACTURING NONCONFORMANCE (E.G., IMPROPER LAMINATION, ABNORMAL FEED GAP, EXPOSED REINFORCEMENT, OR STRUCTURAL ANOMALY) WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138041 ZEBRA Catheter, percutaneous DQY Q'APEL MEDICAL INC. FG 01504-01 FG250825D-01 00857545008219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown