BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3234124 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04794
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL ALIGNED WITH THE DISTAL END OF THE MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED 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 DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING AN ANTEGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 014 NON BSC GUIDE WIRE CROSSED THE LESION AND ON THE FIRST INFLATION OF A 1.5MM X 20MM X 143CM COYOTE¿ ES BALLOON, THE BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 10 SECONDS AND RUPTURED. THE DEVICE WAS RETRIEVED INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING AN ANTEGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 014 NON BSC GUIDE WIRE CROSSED THE LESION AND ON THE FIRST INFLATION OF A 1.5MM X 20MM X 143CM COYOTE ES BALLOON, THE BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 10 SECONDS AND RUPTURED. THE DEVICE WAS RETRIEVED INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333763 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 15543425

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 4F 10CM/MEDIKIT| GUIDEWIRE: CRUISE 014