BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER KIT

    MDR report key: 535689 · Received June 25, 2004

    Report

    Report Number
    535689
    Event Type
    Malfunction
    Date Received
    June 25, 2004
    Date of Event
    June 16, 2004
    Report Date
    June 18, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT STATUS POST MVC (MOTOR VEHICHLE COLLISION), ARROW INTRODUCER KIT USED FOR INSERTION OF SUBCLAVIAN INTRODUCER FOR PA (PULMONARY ARTERY) CATHETER. NEEDLE INSERTED, GUIDEWIRE INSERTED, CATHETER INTRODUCED OVER GUIDEWIRE. RESISTENCE MET WHEN WITHDRAWING GUIDEWIRE; AS WIRE WAS REMOVED, WIRE APPEARED TO SHRED/UNRAVEL. MD (MEDICAL DOCTOR) WAS ABLE TO REMOVE ENTIRE GUIDEWIRE. FEMORAL INSERTION COMPLETED WITHOUT COMPLICATIONS. NO INJURY TO PT. PT ADMITTED S/P MVC, HYPOTENSIVE, LINE REQUIRED FOR FLUID RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS SHEATH INTRODUCER KIT CATHETER INTRODUCER DYB ARROW INTERNATIONAL, INC. * RF4045219

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other