BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOBILIARY TUBE W/JAGWIRE

    MDR report key: 678463 · Received August 30, 2004

    Report

    Report Number
    6000048-2004-00051
    Event Type
    Malfunction
    Date Received
    August 30, 2004
    Date of Event
    July 2, 2004
    Report Date
    July 30, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING THE PHYSICIAN'S PERFORMANCE OF A THERAPEUTIC PROCEDURE ON A PT, THE NASOBILIARY TUBE WITH JAGWIRE WAS BEING USED TO "PLACE AN ENBD TUBE." IT WAS INDICATED THAT WHEN THE JAGWIRE WAS BEING REMOVED FROM THE PT, THE DEVICE TIP BECAME SEPARATED FROM THE DEVICE, AND REMAINED IN THE PT'S BILIARY DUCT. THE TIP WAS NOT REMOVED FROM THE PT'S BILIARY, AS IT WAS FELT THAT THE PT WOULD DEFECATE THE TIP. THE PROCEDURE WAS THEN COMPLETED. THE FOLLOWING DAY THE PHYSICIAN FOUND THAT THE TIP HAD NOT BEEN DEFECATED BY THE PT, CONSEQUENTLY THE DEVICE TIP WAS REMOVED FROM THE PT'S BILIARY DUCT WITH THE AID OF A SNARE. THE COMPLIANANT INDICATED THAT THERE WAS NO ADVERSE AFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASOBILIARY TUBE W/JAGWIRE NASOBILIARY CATHETER FGE BOSTON SCIENTIFIC CORP. NA 4915727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other