BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MINI STICK MAX

    MDR report key: 6686427 · Received June 30, 2017

    Report

    Report Number
    MW5070787
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 30, 2017
    Manufacturer
    NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MINISTICK WAS USED TO GAIN ACCESS TO THE RIGHT FEMORAL ARTERY, THE PHYSICIAN PLACED THE MINISTICK WIRE AND DILATOR/SHEATH THAT COMES WITH THE KIT AND REMOVED THE INNER SHEATH AND WIRE TO REPLACE WITH 4 FRENCH SHEATH/WIRE THEN THE MINISTICK WIRE BROKE OFF INTO THE PATIENT. DR. (B)(6) ASKED FOR CONSULT, DR. (B)(6) WAS IN THE LAB AND WENT INTO ROOM 6 FOR CONSULT. IT WAS DECIDED TO REMOVE THE MINISTICK SHEATH AND PERFORM A CUTDOWN IN WHICH THEY USED A SCALPEL AND HEMOSTAT WAS USED TO RETRIEVE THE WIRE. PRESSURE WAS HELD TO RIGHT GROIN, FLOURO WAS UTILIZED TO DETERMINE ALL OF THE WIRE WAS RETRIEVED AND THEN THE PROCEDURE WAS CONTINUED WITH GAINING ACCESS TO THE LEFT GROIN WITHOUT MINISTICK. POST PROCEDURE RIGHT GROIN WAS SOFT TO TOUCH NO HEMATOMA AND TEGADERM WAS PLACED OVER SITE AND PT DENIED ANY TENDERNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460684 ANGIODYNAMICS MINI STICK MAX VASCULAR ACCESS CATHETER INTRODUCER DRE NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC. H965457530 5191425

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention