BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3792059 · Received May 6, 2014

    Report

    Report Number
    2134265-2014-02401
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 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.: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN, GUIDEWIRE LUMEN, AND IN THE BALLOON. MAGNIFIED EXAMINATION REVEALED A BALLOON PINHOLE OVER THE DISTAL EDGE OF THE MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON 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 OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE CONFIRMED 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED BELOW THE KNEE VESSEL. A 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED AT UNSPECIFIED PRESSURE. HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 1.5MM X 20MM X 143CM COYOTE¿ ES BALLOON CATHETER WAS INITIALLY INFLATED AT 6 ATMOSPHERES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270280 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 16071918

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: MEDTRONIC| INTRODUCER SHEATH: 4F| GUIDEWIRE: CRUISE