BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 3864144 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03240
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    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 HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. A 4.0MM X 150MM X 150CM COYOTE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES AFTER BEING INFLATED FOR 10 SECONDS. PREDILATION WAS PERFORMED USING A 4MM-10CM NON-BSC BALLOON CATHETER, TWO 6MM-100MM NON-BSC STENTS WERE DEPLOYED. POST DILATATION WAS PERFORMED USING A 5MM-6MM STERLING BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337781 COYOTE? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939185401510 16686053

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: TREASURE CRUISE| INTRODUCER SHEATH: DESTINATION 6FR