BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 3002382 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01493
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: "OVER 70 YEARS OLD". (B)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON BURST. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 99% STENOSED, MODERATELY CALCIFIED LESION WAS LOCATED AT THE DISTAL POPLITEAL ARTERY. A 40MMX144CM COYOTE ES BALLOON WAS USED. DURING THE FIRST INFLATION AT 10 ATMS THE BALLOON BURST LONGITUDINALLY. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106109 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 15592157

    Patients

    Seq Age Sex Outcome Treatment
    1