BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 22733840 · Received August 6, 2025

    Report

    Report Number
    2124215-2025-50944
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: DQY, LIT. G4: PREMARKET / 510(K): K111295, K162350.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528612 COYOTE? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H74939185251510 0036058185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown