BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTREAM REGULAR KIT

    MDR report key: 1639366 · Received March 15, 2010

    Report

    Report Number
    1036710-2010-00009
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MSD
    PMA / PMN Number
    K071422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED IS NOT AVAILABLE FOR RETURN TO OUR FACILITY FOR FURTHER INVESTIGATION. THERE WERE NO DEFECTS OR DEVIATIONS NOTED DURING THE BATCH RECORD REVIEW. OUR DFU STATES: "CAUTION: WHEN INTRODUCER NEEDLE IS USED, DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO AVOID POSSIBLE SEVERING OF GUIDEWIRE." THE COATING "JACKET" MAY SEPARATE FROM THE WIRE IF THIS OCCURS, AS EXPERIENCED BY THE USER. THERE IS A RISK OF THIS DEFECT IF THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT ARE NOT FOLLOWED. THEREFORE, THIS IS THE LIKELY ROOT CAUSE OF THE EXPERIENCED EVENT. ANGIOTECH IS WORKING TO REVISE THE CURRENT INSTRUCTIONS FOR USE TO PROVIDE MORE DETAIL REGARDING THE PLACE OF THE GUIDEWIRE INTO THE TISSUE AS WELL AS INCLUDE ADDITIONAL CONSEQUENCES/PATIENT SAFETY COMPLICATIONS WHICH MAY RESULT IN USING THE PRODUCT OFF IFU.

    Description of Event or Problem · 1

    TIP OF HYDROPHILIC WIRE "BROKE OFF" DURING INSERTION OF THE HEMOSTREAM DIALYSIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTREAM REGULAR KIT DIALYSIS CATHETER MSD ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 32101524 92731X3X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other