BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STAB XS .014 300CM J SS

    MDR report key: 608516 · Received May 20, 2005

    Report

    Report Number
    9616099-2005-01023
    Event Type
    Malfunction
    Date Received
    May 20, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 20, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TEFLON SLEEVE PEELED DISTAL ON THE WIRE DURING ANGIOPLASTY. THE WIRE AND STENT WERE PULLED OUT AS A UNIT. THE DELIVERY WAS DIFFICULT BUT WAS A SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STAB XS .014 300CM J SS CARDIOLOGY WIRES & METALS DQX CORDIS DE MEXICO NA X0104643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN