BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 23514035 · Received November 10, 2025

    Report

    Report Number
    2124215-2025-81574
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796893
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928406 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185252210 0033968105 08714729796893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown