BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 5675588 · Received May 24, 2016

    Report

    Report Number
    1219930-2016-00560
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 16, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJT
    PMA / PMN Number
    K952748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKETING VIGILANCE LED AN EVALUATION OF ONE DEVICE KIT OPENED BY THE ACCOUNT WITHOUT THE PACKAGING AND ONE PHOTOGRAPH. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, PMV REVIEW OF COMPLAINT TRENDS, AN ENGINEERING EVALUATION, AND AN EVALUATION OF THE RETURNED DEVICE. THE RECEIVED DEVICE WAS NOTED TO BE A DISENGAGED AND BENT GUIDE WIRE. THE PHOTOGRAPH WAS CONSISTENT WITH THE RECEIVED PRODUCT. ENGINEERING NOTED THAT THE GUIDE WIRE WAS ELONGATED AND BENT. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, "DURING AN IMPLANT PROCEDURE, THE GUIDEWIRE HAD BEEN LOOSED WHILE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331364 2PC VSYS W/9FR INTR KIT LW PFL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N3E0092X

    Patients

    Seq Age Sex Outcome Treatment
    1