BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3833351 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02974
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 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

    DEVICE EVALUATED BY MFR.; VISUAL AND TACTILE INSPECTION REVEALED BLOOD IN THE INFLATION LUMEN. THE CATHETER WAS EXAMINED UNDER MAGNIFICATION. THERE WAS A LONGITUDINAL BALLOON TEAR 9MM LONG ON THE PROXIMAL END OF THE BALLOON. THERE WERE 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 MATERIAL OR MANUFACTURING 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 3MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. ON THE FIRST INFLATION. THE BALLOON RUPTURED AT 14 ATMOSPHERES FOR 60 SECONDS. A NON BSC BALLOON WAS USED BUT STILL UNABLE TO DILATE THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 3MM X 20MM X 144CM COYOTE¿ ES BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. ON THE FIRST INFLATION. THE BALLOON RUPTURED AT 14 ATMOSPHERES FOR 60 SECONDS. A NON BSC BALLOON WAS USED BUT STILL UNABLE TO DILATE THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311650 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135302010 15936721

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: PARENT 6FR| GUIDE WIRE: CRUISE 014