BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 23067194 · Received September 16, 2025

    Report

    Report Number
    2124215-2025-64971
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796817
    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 BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A COYOTE MR 150CM, 2MM X 220MM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 13 ATMOSPHERES FOR FEW SECONDS. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659645 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185202210 0036187781 08714729796817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown