BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 18994224 · Received March 28, 2024

    Report

    Report Number
    2124215-2024-17681
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729767190
    PMA / PMN Number
    K093636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR THERAPY OF THE 99% STENOSED TARGET LESION LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A JUPITER FC GUIDEWIRE WAS ADVANCED INTO THE LESION, BUT THE TIP OF THIS DEVICE GOT WEAKENED. ANOTHER OF THE SAME GUIDEWIRE WAS CROSSED THROUGH THE LESION FOLLOWED BY ADVANCING A 2MM X 40MM X 145CM COYOTE ES BALLOON FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. REVASCULARIZATION WAS ALSO SUCCESSFUL. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723718 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24691 0031396117 08714729767190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown