BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL / XCELA

    MDR report key: 2170042 · Received July 13, 2011

    Report

    Report Number
    1317056-2011-00073
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K093366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER HOSPITAL HAS BEEN CONTACTED AND HAS INDICATED THAT THE USED GUIDEWIRE WILL BE RETURNED TO NAVILYST MEDICAL FOR EVALUATION. UPON RECEIPT OF THE DEVICE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). AN INDWELLING PICC LINE WAS BEING REPLACED BY A 6F NAVILYST VALVED PICC ON (B)(6), 2011. "DURING THE INSERTION OF THE PICC LINE THE GUIDEWIRE 'SHEARED' AND BROKE OFF AT THE DISTAL END AND REMAINED IN THE VEIN. THE WIRE WAS REMOVED WITHOUT INCIDENT, AND ANOTHER PICC LINE WAS SUCCESSFULLY PLACED." THE USER MEDWATCH FURTHER STATED THAT THE "CHIEF TECHNOLOGIST IN IR REPORTED THAT THE WIRE WAS NOT ADVANCING SO THE PERSON INSERTING THE WIRE PULLED BACK AND THE WIRE EITHER SNAGGED PART OF THE SHEATH OR THE NEEDLE AND THAT CAUSED THE WIRE TO BREAK." THE USED GUIDEWIRE WILL BE RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention