BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 3822434 · Received May 20, 2014

    Report

    Report Number
    2134265-2014-02760
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED 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 BALLOON RUPTURE OCCURRED. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. UPON THE FIRST INFLATION, THE BALLOON INFLATED WELL AT 4 ATMOSPHERES. UPON THE SECOND INFLATION, THE BALLOON RUPTURED AT 5 ATMOSPHERES. THE DEVICE WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299634 COYOTE? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939185202210 16370247

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR