BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 23898035 · Received December 26, 2025

    Report

    Report Number
    2124215-2025-93186
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 19, 2025
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796947
    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. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. 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 MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 3.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DEVICE APPEARED TO HAVE RUPTURED WHILE ATTEMPTING TO DILATE THE CALCIFIED PORTION OF THE BELOW-KNEE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502747 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185301510 0037100133 08714729796947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: CROSSLEAD.| GUIDEWIRE: CROSSLEAD.| INTRODUCER SHEATH: PARENT.| INTRODUCER SHEATH: PARENT.| MICRO CATHETER: TORQUE PORTER.| MICRO CATHETER: TORQUE PORTER.