BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIZAI

    MDR report key: 24392601 · Received February 19, 2026

    Report

    Report Number
    3009500972-2026-00002
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 19, 2026
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROCODE: DQO, KRA D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: INITIAL REPORTER NAME: REQUESTED, NOT PROVIDED G4: 510K: N/A THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER), REGISTRATION NO. 2243441, IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER), REGISTRATION NO. 3009500972.

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING REMOVAL OF THE ZIZAI, SLIGHT RESISTANCE WAS FELT. THE DEVICE WAS REMOVED, AND UPON INSPECTION OF THE DEVICE, THE DISTAL TIP APPEARED TO BE ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457025 ZIZAI MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 250701840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown