BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 2870332 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07738
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 AN ANGIOPLASTY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE CALCIFIED LESION BEING TREATED WAS LOCATED IN THE DISTAL SEGMENT OF THE RIGHT CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE OMEGA CORONARY STENT SYSTEM. STENT DAMAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493913816300 0015246522

    Patients

    Seq Age Sex Outcome Treatment
    1