BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2914754 · Received January 14, 2013

    Report

    Report Number
    2134265-2012-08416
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 17, 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

    (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 CAROTID ARTERY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL CAROTID ARTERY. THE 4MM X 40MM X 146CM COYOTE BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 8 ATM AND RUPTURED ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20323 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135404010 14577427

    Patients

    Seq Age Sex Outcome Treatment
    1