BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3864043 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03147
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY USING A 5F SUPERSHEATH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED BRACHIAL ARTERY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED. A 3MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS SELECTED AND ADVANCED TO DILATE THE TARGET LESION; HOWEVER, DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED DUE TO TOTAL OCCLUSION. IT WAS NOTED THAT THE BALLOON RUPTURED UNDER NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340754 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134304010 16236314

    Patients

    Seq Age Sex Outcome Treatment
    1