BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3190409 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04426
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 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 COYOTE ES CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. MAGNIFIED INSPECTION REVEALED A PINHOLE IN THE BALLOON WALL ALIGNED WITH THE DISTAL 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 AND/OR 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL OF ANTERIOR TIBIAL ARTERY. A NON-BSC GUIDE WIRE WAS USED TO CROSS THE TARGET LESION. A 2MM X 20MM X 143CM COYOTE ES MR WAS ADVANCED FOR PREDILATION. IT WAS NOTED THAT THERE WAS NO KINK AND NO RESISTANCE DURING THE PROCEDURE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL OF ANTERIOR TIBIAL ARTERY. A NON-BSC GUIDE WIRE WAS USED TO CROSS THE TARGET LESION. A 2MM X 20MM X 143CM COYOTE ES MR WAS ADVANCED FOR PREDILATION. IT WAS NOTED THAT THERE WAS NO KINK AND NO RESISTANCE DURING THE PROCEDURE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289814 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135202010 14580851

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 3F PARENT (MEDIKIT)| GUIDE WIRE: AGURU HC| INFLATION DEVICE: ENCORE26