BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3791980 · Received May 6, 2014

    Report

    Report Number
    2134265-2014-02376
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 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. 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. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO KINK PRIOR TO USE AND NO RESISTANCE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A 1.5-20 NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270620 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 16245901

    Patients

    Seq Age Sex Outcome Treatment
    1