BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE ES

    MDR report key: 17343529 · Received July 18, 2023

    Report

    Report Number
    2124215-2023-37432
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    July 12, 2023
    Report Date
    December 25, 2023
    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

    Additional Manufacturer Narrative · 0

    H6 DEVICE CODE HAS BEEN CORRECTED TO ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR THERAPY FOR A CHRONIC TOTAL OCCLUSION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED POSTERIOR TIBIAL ARTERY. A JUPITER FC GUIDEWIRE WAS ADVANCED, BUT THE TIP BECAME WORN OUT AND FAILED TO CROSS THE LESION. THE GUIDEWIRE WAS REPLACED WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE, BUT IT TOOK LONGER TO PASS THE LESION AND THE TIP WAS BROKEN. ANOTHER OF SAME NON-BSC GUIDEWIRE WAS USED TO SUCCESSFULLY CROSS THE LESION. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. AFTER DILATATION USING A 2MM NON-COMPLIANT BALLOON, ADDITIONAL DILATATION WAS PERFORMED WITH A BALLOON OF BIGGER SIZE AND COMPLETING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THERE WERE NO ISSUES WITH THE 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR THERAPY FOR A CHRONIC TOTAL OCCLUSION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED POSTERIOR TIBIAL ARTERY. A JUPITER FC GUIDEWIRE WAS ADVANCED, BUT THE TIP BECAME WORN OUT AND FAILED TO CROSS THE LESION. THE GUIDEWIRE WAS REPLACED WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE, BUT IT TOOK LONGER TO PASS THE LESION AND THE TIP WAS BROKEN. ANOTHER OF SAME NON-BSC GUIDEWIRE WAS USED TO SUCCESSFULLY CROSS THE LESION. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. AFTER DILATATION USING A 2MM NON-COMPLIANT BALLOON, ADDITIONAL DILATATION WAS PERFORMED WITH A BALLOON OF BIGGER SIZE AND COMPLETING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101157 COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION 24701 0031098781 08714729767329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown