BEUDAMED
    FDA Adverse Event Other Summary report: N

    EN-SNARE RETRIEVAL SYSTEM

    MDR report key: 450441 · Received March 24, 2003

    Report

    Report Number
    1036710-2003-00001
    Event Type
    Other
    Date Received
    March 24, 2003
    Date of Event
    December 31, 2002
    Report Date
    January 2, 2003
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    MMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT HAD HAD AN INSERTION OF A S/P SWAN-GANZ CATHETER INTO THE LEFT SUBCLAVIAN VEIN THAT WAS STUCK INSIDE THE VEIN. ATTEMPTS AT RETRIEVAL OVER A GUIDE WIRE RESULTED IN BREAKAGE OF THE CATHETER AND RESIDUAL FRAGMENT THAT REMAINED STUCK IN THE VEIN. INITIAL FLUOROSCOPY SHOWED CATHETER FRAGMENT AND A GUIDEWIRE WITHIN THE LEFT INFRACLAVICULAR REGION. A SNARE WAS INTRODUCED UNTIL IT REACHED THE CATHETER FRAGMENT. IT WAS ENGAGED BY THE SNARE. UPON RETRACTION, THE SNARE BROKE OFF BUT REMAINED WITHIN THE VEIN. ANOTHER SNARE OF SMALLER SIZE WAS INTRODUCED. THE FIRST SNARE WAS RETRIEVED AND THEN THE CATHETER FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EN-SNARE RETRIEVAL SYSTEM VASCULAR SNARE AND CATHETER MMX MEDICAL DEVICE TECHNOLOGIES, INC. * 22310F6H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention