BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3896860 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03659
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 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 DEVICE WAS NOT RETURNED. 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 A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED USING A 6F90CM NON BSC SHEATH VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY IN THE LEFT LOWER ANKLE. AFTER CROSSING THE LESION WITH A 0.014X235CM NON-BSC GUIDEWIRE, A 1.5MM X 20MM X 143CM COYOTE¿ ES BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. THIS DEVICE WAS ADVANCED ALONG THE GUIDE WIRE AND CROSSED THE LESION DESPITE MILD RESISTANCE. DURING DILATATION AT THE LESION, THE PRESSURE GAUGE OF INFLATOR DID NOT MOVE UPWARD. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THEY NOTICED THAT THE BALLOON GOT FRACTURED LONGITUDINALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374073 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 16230626

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH:6F90CM SHEATHLESSPV| GUIDEWIRE:NAVEED0.014X235CM