BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 15234909 · Received August 16, 2022

    Report

    Report Number
    2124215-2022-28049
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 23, 2022
    Report Date
    August 16, 2022
    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 DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BELOW-THE-KNEE VESSEL. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION OVER A JUPITER FC3 GUIDEWIRE. HOWEVER, DURING THE PROCEDURE, THE DEVICE GOT STUCK WITH THE GUIDEWIRE AND HAD TO BE REMOVED AS ONE UNIT. IT WAS NOTED THAT THE GUIDEWIRE COULD NOT BE REMOVED FROM THE BALLOON CATHETER OUTSIDE THE PATIENT DUE TO STRONG RESISTANCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915919 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24701 0028681308 08714729767329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GUIDE CATHETER: GOGO CATHETER| INFLATION DEVICE: NIPRO GM30| INTRODUCER SHEATH: PARENT 60| MICRO CATHETER: PROMINENTNEO