BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEBRA

    MDR report key: 24357076 · Received February 16, 2026

    Report

    Report Number
    3015614-2026-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 16, 2026
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    DQY
    UDI-DI
    00857545008233
    PMA / PMN Number
    K240746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JANUARY 16, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA CATHETER. DURING A RADIAL MMA EMBOLIZATION PROCEDURE, THE USER OBSERVED A KINK IN THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CATHETER WITH NO REPORTED PATIENT INJURY. EVALUATION OF THE RETURNED DEVICE CONFIRMED A LOCALIZED CATHETER WALL BREACH/FRACTURE LOCATED APPROXIMATELY 9 CM DISTAL TO THE STRAIN RELIEF, AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. VISUAL INSPECTION CONFIRMED A LOCALIZED KINK IN THE SHAFT AT THIS SAME LOCATION, CONSISTENT WITH THE REPORTED COMPLAINT. ADDITIONAL KINKS WERE ALSO OBSERVED APPROXIMATELY 5 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING OR PITCH VARIATION, AND THE DISTAL TIP SHOWED NO ABNORMALITIES. THE OBSERVED DAMAGE PATTERN WAS CONSISTENT WITH LOCALIZED MECHANICAL DEFORMATION/STRETCHING. NO EVIDENCE OF A DESIGN ANOMALY OR MANUFACTURING DEFECT WAS OBSERVED WITHIN THE SCOPE OF THE RETURNED PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501925 ZEBRA Catheter, percutaneous DQY Q'APEL MEDICAL INC. FG 01764-01 FG250925D-05 00857545008233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown