BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3932570 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-03983
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    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. DEVICE EVALUATED BY MFR. THE CATHETER WAS TACTILELY AND VISUALLY INSPECTED; THE SHAFT WAS KINKED SLIGHTLY IN TWO PLACES 78CM FROM THE DISTAL TIP. THE BALLOON AND SHAFT WERE INSPECTED UNDER MAGNIFICATION. THERE WAS A BALLOON PINHOLE OVER THE MARKERBAND; THE INSPECTION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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 A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. DURING PROCEDURE THE BALLOON WAS INFLATED ONCE AT 6 ATMOSPHERES AND CONTRAST DYE LEAKED WAS FOUND FROM THE COMPLAINT DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT. 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
    409485 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 16851408

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6FR SHEATH (TERUMO)| GUIDE WIRE: AGOSAL 014 (ST.JUDE MEICAL)