BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 22461807 · Received July 9, 2025

    Report

    Report Number
    2124215-2025-40749
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729796800
    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

    D2B: PRO CODE: DQY, LIT. 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 VESSEL BELOW THE KNEE. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162411 COYOTE? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185201510 0035450500 08714729796800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown