BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3923636 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03885
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 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. (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 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION, A 2MM X 20MM X 142CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED HOWEVER IT RUPTURED AT 8 ATMOSPHERES AT AN UNKNOWN NUMBER OF INFLATION DUE TO CALCIFICATION OF THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND NO SEGMENT OF THE BALLOON WAS DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. 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
    399462 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134202010 15397362

    Patients

    Seq Age Sex Outcome Treatment
    1