BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1003686 · Received November 26, 2007

    Report

    Report Number
    1003686
    Event Type
    Malfunction
    Date Received
    November 26, 2007
    Date of Event
    April 14, 2007
    Report Date
    October 31, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRAUMA PT UNDERWENT BEDSIDE INSERTION OF IVC FILTER. UPON DEPLOYMENT OF THE FILTER, 3 OF THE PRONGS APPEARED TO HAVE BEEN CAUGHT IN THE SHEATH. THERE WAS SUBSEQUENTLY DIFFICULTY DEPLOYING THE FILTER. AFTER MANIPULATION OF THE FILTER AND WIRE THE DEPLOYMENT OF THE FILTER WAS ABLE TO BE COMPLETED. HOWEVER 3 OF THE PRONGS OF THE FILTER REMAINED ENTANGLED. ALTHOUGH IMAGING STUDIES REVEALED THE FILTER TO BE IN GOOD POSITION, AND THE INVOLVED HEALTHCARE PROVIDERS WERE OF THE OPINION THAT IT WAS NOT LIKELY THAT THE FILTER WOULD MIGRATE, THERE WAS CONCERN THAT FOR PREVENTION PURPOSES THE FILTER MAY NOT HAVE BEEN SATISFACTORY. THE PT WAS SUBSEQUENTLY TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL OF THIS DEVICE AND SUCCESSFUL PLACEMENT OF ANOTHER. REPORTER INDICATED THE FILTER WAS MANUFACTURED BY BARD, HOWEVER, NO INFO WAS PROVIDED REGARDING CATALOG # OR BRAND NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DTK DTK BARD PERIPHERAL VASCULAR, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR