BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 3061172 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02337
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 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 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 VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY WITH A 4FR NON-BSC SHEATH. THE 95% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES DURING THE INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE INFLATED TO 4ATMS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162423 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 15249641

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE : EVEREST| GUIDE WIRE: CRUISE 0.014INCH