BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 3061239 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02338
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    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 THE TIME OF EVENT: OVER 18 YEARS. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3X60MM TARGET LESION WAS LOCATED IN THE CALCIFIED ANTERIOR TIBIAL ARTERY. A 1.5MM X 40MM X 150CM COYOTE BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. UPON THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. THE DEVICE WAS INTACT WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A 15-20 COYOTE ES. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162712 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939186150410 15708197

    Patients

    Seq Age Sex Outcome Treatment
    1