BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEBRA

    MDR report key: 24480527 · Received March 2, 2026

    Report

    Report Number
    3015614-2026-00011
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 1, 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
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A NEUROVASCULAR PROCEDURE PERFORMED BY DR. (B)(6), A ZEBRA WAS USED VIA A 7F SLENDER INTRODUCER SHEATH. AFTER SELECTION OF THE RIGHT INTERNAL CAROTID ARTERY AND REMOVAL OF A 5F SIM2 COOK CATHETER, THE ADJUNCTIVE DEVICES (VECTA 46, V17, AND SYNCHRO) WERE ADVANCED THROUGH THE ZEBRA CATHETER, A FRACTURE WAS OBSERVED AT THE DISTAL SEGMENT. A 0.035" GLIDEWIRE WOULD NOT PASS THROUGH THE FRACTURED REGION. THE ZEBRA CATHETER WAS GENTLY WITHDRAWN FROM THE PATIENT; THE SHAFT REMAINED ATTACHED DURING REMOVAL, BUT COMPLETELY SEPARATED AFTER EXITING THE SHEATH. AT THE TIME OF THIS REPORT, Q'APEL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340503 ZEBRA Catheter, percutaneous DQY Q'APEL MEDICAL INC. FG 01764-01 FG250925D-05 00857545008233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown