BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 24263172 · Received February 4, 2026

    Report

    Report Number
    2124215-2026-06512
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796817
    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

    G4: PREMARKET / 510(K): K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325542 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185202210 0036080161 08714729796817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown