BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI STICK MAX - COAXIAL MICROINTRODUCER KIT N/A UNK

    MDR report key: 8194420 · Received December 21, 2018

    Report

    Report Number
    MW5082549
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 7, 2018
    Report Date
    December 20, 2018
    Manufacturer
    NAVILYST MEDICAL INC. / ANGIO DYNAMICS, INC.
    Product Code
    DQX
    UDI-DI
    H965457500
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A GROSHONG CATHETER PLACEMENT; A MINI STICK MAX/ COAXIAL MICROINTRODUCER KIT MADE BY (B)(4) WAS USED. A PORTION OF THE INTRODUCER SHEATH BROKE OFF DURING WITHDRAWAL OVER A 0.035 WIRE. THE PORTION RETAINED WAS 8.3 CM AS EVIDENCED BY THE REMAINING 1.7 CM SHEATH THAT WAS ATTACHED TO THE ORANGE HUB. THE RETAINED PORTION WAS LOCATED IN THE RIGHT ATRIUM. CONFIRMED BY CAT SCAN. DATE OF USE: (B)(6) 2018; DIAGNOSIS OR REASON FOR USE: LONG TERM ANTIBIOTIC USE; IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027718 MINI STICK MAX - COAXIAL MICROINTRODUCER KIT N/A UNK WIRE, GUIDE, CATHETER DQX NAVILYST MEDICAL INC. / ANGIO DYNAMICS, INC. H965457500 5396570 H965457500

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention