BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE

    MDR report key: 21677029 · Received March 24, 2025

    Report

    Report Number
    2124215-2025-17701
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 24, 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 (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 VESSEL BELOW THE KNEE. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490048 COYOTE CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185201510 0035224439 08714729796800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: GLADIUS MG.| INFLATION DEVICE: PS25.| INTRODUCER SHEATH: CROSSROAD 6F.