BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL LINE KIT

    MDR report key: 1243071 · Received November 14, 2008

    Report

    Report Number
    1036844-2008-00238
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 27, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    k810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE INFO WAS REC'D BY MEDWATCH REPORT. IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT. REPORT STATES: LEFT FEMORAL ARTERY LINE PLACEMENT IN ER. AFTER THE CATHETER WAS PLACED OVER THE SPRING WIRE GUIDE (SWG), THE SWG SHEARED, AND COULD NOT BE REMOVED WITHOUT REMOVAL OF THE CATHETER, WHICH WAS ACCOMPLISHED. THE ENTIRE SWG WAS RETRIEVED, BUT THERE WAS UNRAVELING OF THE SWG WITH CONCERN THAT A PIECE OF IT COULD BREAK OFF; THAT DID NOT HAPPEN. THERE WAS ARTERIAL BLEEDING FROM THE SITE THAT REQUIRED FIFTEEN MINUTES OF DIRECT PRESSURE TO CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE KIT ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR