BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3180883 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04193
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 29, 2013
    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.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS SELECTED TO PREDILATE THE VESSEL AFTER A NON-BSC GUIDE WIRE WAS ABLE TO CROSS THE LESION. THE BALLOON CATHETER WAS INFLATED TWICE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES BECAUSE OF THE SEVERITY OF CALCIFICATION. NO KINKS WERE OBSERVED PRIOR TO USE AND NO RESISTANCE WAS ENCOUNTERED DURING PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279777 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 15908368

    Patients

    Seq Age Sex Outcome Treatment
    1