BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 23995197 · Received January 7, 2026

    Report

    Report Number
    2124215-2026-01056
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796893
    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.

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. G4 - PREMARKET / 510(K) #: K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. 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. IT WAS FURTHER REPORTED THAT WHEN IT WAS USED FOR A CHRONIC TOTAL OCCLUSION IN THE INFRA POPLITEAL LESION, IT APPEARS THAT A RUPTURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55174 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185252210 0036548230 08714729796893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male BALLOON CATHETER - COYOTE| BALLOON CATHETER - COYOTE| GUIDEWIRE - JUPITER| GUIDEWIRE - JUPITER| MICRO CATHETER - PROMINENT| MICRO CATHETER - PROMINENT