BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 19209212 · Received April 29, 2024

    Report

    Report Number
    2124215-2024-25175
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729767329
    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 FOR THE SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY CHRONIC TOTAL OCCLUSION. A JUPITER S6 GUIDEWIRE WAS ADVANCED INTO THE LESION; HOWEVER, THE TIP WAS WEAKENED DUE TO THE SEVERELY CALCIFIED LESION. NEW WIRING WAS PERFORMED USING THE SAME DEVICE TO PASS THROUGH THE LESION. AFTER THE GUIDEWIRE WAS REPLACED, A 1.5MM X 20MM X 142CM COYOTE ES BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 7 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 2MM BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021889 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24701 0032047399 08714729767329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown