BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 3030597 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01937
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED ANTERIOR TIBIAL ARTERY. A NON-BSC GUIDE WIRE WAS USED TO CROSS THE LESION AND THE 2MM X 20MM X 143CM COYOTE ES BALLOON WAS TO BE USED FOR PREDILATATION. THE BALLOON WAS INFLATED ONCE TO 14ATMS AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134567 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135202010 15238122

    Patients

    Seq Age Sex Outcome Treatment
    1 55CM 4.5FR PARENT (MEDIKIT) INTRODUCER SHEATH| 175CM CRUISE(ST. JUDE MEDICAL) GUIDE WIRE| TREASURE SX9-12 (ST. JUDE MEDICAL) GUIDE WIRE