BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE

    MDR report key: 20799301 · Received November 27, 2024

    Report

    Report Number
    2124215-2024-74554
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729796800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): LIT G4 - PMA/510(K) # FIELD ON 3500A FORM: K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FACILITY MEDWATCH# 5160289 THAT THE BALLOON COVER DETACHED INSIDE THE PATIENT. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE CLEAR CATHETER TIP COVER WAS NOT EASILY IDENTIFIED, AND THE CATHETER WAS ABLE TO BE THREADED WITH THE COVER STILL IN PLACE WHICH CAUSED THE COVER TO BE RETAINED REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849919 COYOTE CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185201510 08714729796800

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention