BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3843967 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-03049
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 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: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH NO PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE INFLATION LUMEN AND A STOPCOCK WAS ATTACHED TO THE HUB. THE CATHETER WAS VISUALLY AND TACTILELY INSPECTED AND NO DAMAGE OR IRREGULARITIES WAS NOTED. EXAMINATION OF THE BALLOON UNDER MAGNIFICATION REVEALED A LONGITUDINAL TEAR (10MM LONG) ON THE DISTAL END OF THE BALLOON. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THERE WAS NO MATERIAL OR MANUFACTURING DEFICIENCIES NOTED. 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 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.5MM X 20MM X 144CM COYOTE ES MR BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIFTH INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321446 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135252010 15291536

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MEDIKIT/6F| GUIDEWIRE: CRUISE/SJM