BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM)

    MDR report key: 1359766 · Received March 5, 2009

    Report

    Report Number
    2134265-2009-00805
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    K032884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NFA DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY PROCEDURE, A MALFUNCTION OF THE DEVICE OCCURRED. THE LESION BEING TREATED WAS A SAPHENOUS VEIN GRAFT WAS TO THE DISTAL RIGHT CORONARY ARTERY (SVG/DIST RCA) THAT WAS MILDLY TORTUOUS WITH MODERATE CALCIFICATION. THE PHYSICIAN STATED THAT "WHEN DEPLOYING THE BASKET THE SHAFT FRAYED." THE PHYSICIAN USED ANOTHER FILTERWIRE AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH NO PATIENT INJURY OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM) NIM STENT CAROTID NIM BOSTON SCIENTIFIC 20100-190 0000828203

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR