BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 23234213 · Received October 7, 2025

    Report

    Report Number
    2124215-2025-70690
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    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 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCE FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651012 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185202210 0036002168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown