BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE?

    MDR report key: 24756323 · Received April 1, 2026

    Report

    Report Number
    2124215-2026-17903
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729796183
    PMA / PMN Number
    K111295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REMOVAL DIFFICULTY, BALLOON BURST AND MARKERBAND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. PATIENT WAS PRESENTED WITH VASCULOPATHY WITH EXTENSIVE VESSEL DISEASE AND HAS RENAL DISEASE ON HEMODIALYSIS (FISTULAS LEFT ARM AND LEG). A 2.0MM X 120MM X 150CM, MR COYOTE BALLOON CATHETER WAS SELECTED FOR USE. FISTULOGRAPHY WAS COMPLETED ON THE LEFT ARM OF THE PATIENT. UPON RETRACTING THE BALLOON BACK INTO THE WIRE, RESISTANCE WAS MET. CONSEQUENTLY, THE BALLOON BURST AND BOTH THE PROXIMAL AND DISTAL MARKERS "SHEARED OFF" IN THE MID-CALF OF THE LEFT LEG. THE DISTAL MARKER WAS SUCCESSFULLY SNARED AND RETRIEVED FROM THE VESSEL. HOWEVER, THE PROXIMAL MARKER WAS LODGED IN A BRANCH OF THE PERONEAL ARTERY AND RETRIEVAL WAS NOT ATTEMPTED AS IT WAS NOT CLINICALLY SIGNIFICANT. THE ENTIRE BALLOON APPEARED TO BE PRESENT AND THAT NO PARTS OF THE BALLOON ITSELF WERE BELIEVED TO HAVE BEEN LEFT INSIDE THE PATIENT. THE PATIENT WENT TO THE WARD POST PROCEDURE. THE PATIENT WAS FULLY RECOVERED AND IS EXPECTED TO BE DISCHARGED. IT WAS FURTHER REPORTED THAT THE LESION WAS NEAR OCCLUSIVE, NON-TORTUOUS AND SEVERELY CALCIFIED. THE DETACHED PROXIMAL MARKER WILL NOT BE REMOVED AS IT WAS LODGED IN A SMALL BRANCH OF THE PERONEAL ARTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REMOVAL DIFFICULTY, BALLOON BURST AND MARKERBAND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. PATIENT WAS PRESENTED WITH VASCULOPATHY WITH EXTENSIVE VESSEL DISEASE AND HAS RENAL DISEASE ON HEMODIALYSIS (FISTULAS LEFT ARM AND LEG). A 2.0MM X 120MM X 150CM, MR COYOTE BALLOON CATHETER WAS SELECTED FOR USE. FISTULOGRAPHY WAS COMPLETED ON THE LEFT ARM OF THE PATIENT. UPON RETRACTING THE BALLOON BACK INTO THE WIRE, RESISTANCE WAS MET. CONSEQUENTLY, THE BALLOON BURST AND BOTH THE PROXIMAL AND DISTAL MARKERS "SHEARED OFF" IN THE MID-CALF OF THE LEFT LEG. THE DISTAL MARKER WAS SUCCESSFULLY SNARED AND RETRIEVED FROM THE VESSEL. HOWEVER, THE PROXIMAL MARKER WAS LODGED IN A BRANCH OF THE PERONEAL ARTERY AND RETRIEVAL WAS NOT ATTEMPTED AS IT WAS NOT CLINICALLY SIGNIFICANT. THE ENTIRE BALLOON APPEARED TO BE PRESENT AND THAT NO PARTS OF THE BALLOON ITSELF WERE BELIEVED TO HAVE BEEN LEFT INSIDE THE PATIENT. THE PATIENT WENT TO THE WARD POST PROCEDURE. THE PATIENT WAS FULLY RECOVERED AND IS EXPECTED TO BE DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599095 COYOTE? CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION H74939185201210 0035264316 08714729796183

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H