BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 4110133 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05656
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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 BURST OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY UTILIZING CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED ARTERY BELOW THE LEFT KNEE. AFTER A NON BSC GUIDEWIRE CROSSED THE LESION, A 3MM X 40MM X 145CM COYOTE¿ BALLOON CATHETER WAS ADVANCED TO THE LESION. THE PHYSICIAN DILATED THE LESION BY INFLATING THE BALLOON AT 5 ATMOSPHERES (ATMS) AND IT WAS NOTED ON THE ANGIOGRAM THAT A CONTRAST MEDIA LEAKED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT IT WAS A LONGITUDINAL RUPTURE. THE DEVICE WAS EXCHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590292 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134304010 16796472

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH:DESTINATION6F 90CM| GUIDEWIRE:CRUISE0.014×175CM