BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 5697464 · Received June 3, 2016

    Report

    Report Number
    1219930-2016-00587
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 24, 2016
    Report Date
    May 26, 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 MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE 2PC VSYS/PRT/LOCKS, 4NDL LW PFL OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE REPORTED CONDITION FOR THIS INCIDENT WAS THAT THE SHEATH WAS DAMAGED. THE VISUAL INSPECTION OF THE DEVICE NOTED THAT THE DISTAL END SHEATH WAS DAMAGED. REPLICATION OF THE REPORTED CONDITION MAY BE DUE TO ROUGH HANDLING OF THE DEVICE. THE EVENT DID NOT MEET THE REGULATORY REPORTING CRITERIA. A REVIEW OF THE CURRENT HISTORICAL COMPLAINT DATA REVEALS NO TREND FOR A DEVICE RELATED FAILURE FOR THIS CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SHEATH WAS FRACTURED DURING OPERATION SO THE SURGEON DECIDED TO USE ANOTHER BRAND TO CONTINUE THE SURGERY. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351580 2PC VSYS W/9FR INTR KIT LW PFL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N5A0944X

    Patients

    Seq Age Sex Outcome Treatment
    1