BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 2862919 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07388
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    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). DEVICE EVALUATED BY MANUFACTURER: 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 PERIPHERAL INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION LOCATED AT THE MODERATELY TORTUOUS AND CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY. A 2.0MM X 22.0MM X 150 CM COYOTE BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS FIRST INFLATED AT 6ATM. UPON 2ND INFLATION AT 10 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939185202210 15275230

    Patients

    Seq Age Sex Outcome Treatment
    1