BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 23265064 · Received October 10, 2025

    Report

    Report Number
    2124215-2025-72056
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K093636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE ANTERIOR TIBIAL ARTERY (ATA), WIRING WAS INITIALLY ATTEMPTED USING A JUPITER SFC GUIDEWIRE. HOWEVER, DUE TO SEVERE CALCIFICATION OF THE LESION, THE WIRING PROCESS WAS PROLONGED. THE GUIDEWIRE TIP WEAKENED DURING THIS ATTEMPT. THE DEVICE WAS THEN REPLACED WITH ANOTHER JUPITER SFC, WHICH WAS SUCCESSFULLY ADVANCED ACROSS THE LESION. SUBSEQUENTLY, BALLOON INFLATION WAS ATTEMPTED USING A 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER. DURING THE INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON OF THE SAME TYPE, BUT DUE TO PROCEDURAL NEEDS, BALLOON SIZE WAS INCREASED TO 2.5 MM TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303729 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION H74939135152010 0033156560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: JUPITER SFC