BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 22682800 · Received July 31, 2025

    Report

    Report Number
    2124215-2025-53171
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 31, 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

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). D2B: DQY, LIT PRO CODE (PRODUCT 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 POSTERIOR TIBIAL ARTERY A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE THIRD INFLATION AT 10 ATMOSPHERES WHILE INCREASING. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221704 COYOTE? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185201510 0033146248 08714729796800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown