BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE¿ ES

    MDR report key: 2971474 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00884
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL ANTERIOR TIBIAL ARTERY. WHILE LOADING THE 2.5 MM X 20 MM X 144 CM COYOTE ES BALLOON CATHETER INTO A NON-BSC WIRE, THE PHYSICIAN WENT IN TOUCH IN LATERAL FASHION, WITH NO SUPPORT. THE BALLOON GOT CAUGHT IN AN UNSPECIFIED IMPLANTED STENT. THE PHYSICIAN TRIED TO REMOVE THE BALLOON FROM THE BODY AND THE SHAFT BROKE. THE DETACHED SHAFT BALLOON WAS REMOVED WITH A SNARE. THE PHYSICIAN ELECTED NOT TO PROCEED WITH THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75624 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135252010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention