BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 16277356 · Received February 1, 2023

    Report

    Report Number
    2124215-2023-03600
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729767169
    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 PRESENTED WITH LOWER EXTREMITY ARTERIAL DISEASE AND UNDERWENT ENDOVASCULAR THERAPY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. VASCULAR ACCESS WAS OBTAINED USING THE IPSILATERAL ANTEGRADE APPROACH. AFTER INSERTING A NON-BOSTON SCIENTIFIC (BSC) SHEATH AND PLACING A NON-BSC GUIDE CATHETER, A JUPITER GUIDEWIRE AND A NON-BSC MICRO CATHETER WERE USED TO CROSS THE LESION. A NON-BSC BALLOON CATHETER WAS INITIALLY ADVANCED FOR DILATATION BUT FAILED TO CROSS THE LESION. A 1.2MMX15MMX142CM EMERGE BALLOON CATHETER WAS ADVANCED BUT RUPTURED AT THE DISTAL TO ANTERIOR PART ON THE THIRD OR FOURTH INFLATION. THE SAME EMERGE BALLOON WAS USED TO DILATE THE LESION AGAIN FOLLOWED BY THE SAME INITIALLY USED NON-BSC BALLOON. THE PHYSICIAN DECIDED TO USE A BIGGER SIZE BALLOON AND ADVANCED A 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH ANOTHER OF SAME DEVICE FOLLOWED BY USING ANOTHER NON-BSC BALLOON COMPLETING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998267 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24691 0030073853 08714729767169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GUIDE CATHETER: MACH 1 6FR ST 55 CM| GUIDEWIRE: JUPITER FC, GLADIUS| INFLATION DEVICE: MERIT| INTRODUCER SHEATH: HALO ONE 6FR| MICRO CATHETER: PROMINENT