BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 3080778 · Received April 26, 2013

    Report

    Report Number
    2134265-2013-02648
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    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 WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 PERIPHERAL TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. THE 1.5 X 20MM COYOTE ES MR BALLOON CATHETER WAS ADVANCED THROUGH A 6FR NON BSC INTRODUCER SHEATH AND OVER A NON BSC GUIDE WIRE. THE BALLOON WAS INFLATED AT 10ATMS AND RUPTURED ON THE 1ST INFLATION. THE BALLOON WAS EXCHANGED TO A 2.0 X 20MM NON BSC, THEN COMPLETED THE PROCEDURE WITH A 2.0 X 220MM COYOTE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180743 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 14546486

    Patients

    Seq Age Sex Outcome Treatment
    1 CRUISE: GUIDE WIRE| PARENT 6FR: INTRODUCER SHEATH