BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUNET TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT 4F

    MDR report key: 8363116 · Received February 21, 2019

    Report

    Report Number
    MW5084244
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    February 8, 2019
    Report Date
    February 19, 2019
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REQUIRED A CHEST PORT FOR CHEMOTHERAPY. WHEN PLACING PORT UNDER FLUOROSCOPY, THE RIGHT INTERNAL JUGULAR WAS IDENTIFIED. THE WIRE WAS PLACED AND THE CATHETER WAS ADVANCED. OVER THE WIRE, THE CATHETER WAS THEN REMOVED AND A PEEL-AWAY SHEATH PLACED. DURING A REPEAT ACCESS, IT WAS NOTED THE FLOPPY END OF THE WIRE HAD BEEN FRACTURED. USING ULTRASOUND AND A GOOSENECK SNARE DEVICE, THE FLOPPY END OF THE WIRE WAS REMOVED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153944 FLUNET TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT 4F MICRO-INTRODUCER DYB GALT MEDICAL CORPORATION KIT-039-03 G18278173

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R