BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2830298 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06808
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: MAGNIFIED INSPECTION REVEALED NO DAMAGE OR IRREGULARITIES. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE AT THE DISTAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED SCRATCHES IN THE BALLOON MATERIAL PROXIMALLY FROM THE PINHOLE. 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 DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE 1.5 X 20 MM X 142 CM COYOTE ES OTW BALLOON WAS INFLATED, AND RUPTURED AT 14 ATMS ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.5 X 20 MM X 142 CM COYOTE ES OTW BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE 1.5 X 20MM X 142CM COYOTE ES OTW BALLOON WAS INFLATED, AND RUPTURED AT 14ATMS ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.5 X 20MM X 142CM COYOTE ES OTW BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 14565679

    Patients

    Seq Age Sex Outcome Treatment
    1