BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 11138858 · Received January 8, 2021

    Report

    Report Number
    2134265-2021-00087
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 8, 2021
    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

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39142 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24691 0025819261 08714729767190

    Patients

    Seq Age Sex Outcome Treatment
    1