BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1132744 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02426
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. THE DEVICE WAS NOT RETURNED SO NO PRODUCT ANALYSIS WAS PERFORMED. MANUFACTURING RECORDS WERE REVIEWED FOR THIS BATCH. ALL PROCESS MONITORING TESTS WERE PERFORMED AND ALL TESTS MET SPECIFICATION REQUIREMENTS. THE EVENT DESCRIPTION IS LIKELY DESCRIBING A FAILURE TO DEPLOY. THE DEVICE KNOB IS DESIGNED TO BE TURNED COUNTER CLOCKWISE. THE STATEMENT "THE PRODUCT WAS TURNED AGAINST CLOCKWISE" SEEMS TO INDICATE THAT THE KNOB WAS TURNED COUNTERCLOCKWISE BUT THIS CANNOT BE DETERMINED WITH CERTAINTY. ONE REASON FOR FAILURE OF THE DEVICE TO DEPLOY IS FAILURE TO OPEN THE ROTATING HEMOSTASIS VALVE (RHV). THIS WOULD BE CONSIDERED MISURE WHICH WOULD MATCH THE ORIGINAL EVENT DESCRIPTION OF "APPARENTLY DUE TO MISUSE." HOWEVER, THE ACTUAL FAILURE OF THE DEVICE IS NOT DEFINITIVELY KNOWN, SO THE ROOT CAUSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, "THE PRODUCT DID NOT WORK PROPERLY, APPARENTLY DUE TO MISUSE." ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED "FAILURE IMPLANT. THE PRODUCT WAS TURNED AGAINST CLOCKWISE." THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C72601

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR