BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERNATIONAL INC

    MDR report key: 2737438 · Received October 13, 2005

    Report

    Report Number
    2737438
    Event Type
    Injury
    Date Received
    October 13, 2005
    Date of Event
    October 10, 2005
    Report Date
    October 12, 2005
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INSERTED ARROW ARTERIAL CATHETER INTO THE RIGHT RADIAL ARTERY. HAD BLOOD FLOW UP INTO THE SYRINGE. ADVANCED GUIDE WIRE AS PER PROCEDURE. INSERTED CATHETER OVER THE GUIDE WIRE. NO BLOOD FLOW WHEN WIRE WAS REMOVED. CATHETER PULLED OUT ABOUT 1CM. BLOOD FLOW OBTAINED. ADVANCED CATHETER BACK TO THE HUB. NO BLOOD FLOW. REMOVED CATHETER. WHEN THE CATHETER WAS REMOVED IT WAS MISSING APPROX 15-20MM OF THE CATHETER. CATHETER APPEARS TO HAVE TORN OFF. PT UNDERWENT X-RAYS AND ULTRASOUND TO DETERMINE LOCATION OF CATHETER END. PT SURGERY ON (B)(6) 2005, TO REMOVE CATHETER AND DAMAGED VESSEL. ACQUIRED CATHETER FROM ICU, BUT THE OPERATING ROOM HAD DISCARDED. THE PIECE OF CATHETER REMOVED, DISCOVERED WHEN PATHOLOGY WAS REVIEWING SPECIMEN ONLY THE VESSEL AND CLOT WERE PRESENT. PHYSICIAN WHO REMOVED THE CATHETER FELT LIKE THE BREAKAGE WAS DUE TO SHEARING. WILL SEND PORTION OF CATHETER RECOVERED TO ARROW INTERNATIONAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL INC RADIAL ARTERY CATHETERIZATION SET DQY ARROW INTERNATIONAL INC RA-04120 CF6037312

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R