BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2920306 · Received January 17, 2013

    Report

    Report Number
    2134265-2012-08561
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    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 MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED ANTERIOR TIBIAL ARTERY. USING A NON-BSC SHEATH AND GUIDEWIRE, THE 4MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED AND BEING USED TO DILATE THE LESION. THE BALLOON WAS INFLATED TO 6 ATMS THEN TO 12 ATMS AND RUPTURED AT 12 ATMS UPON THIRD INFLATION. 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
    26472 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135402010 14565441

    Patients

    Seq Age Sex Outcome Treatment
    1