BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRES

    MDR report key: 1023835 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00963
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2008-00954. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT CATHETER BECAME FROZEN ON THE GUIDE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS CIRCUMFLEX (CX). THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE. THEN, THE 3.00X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) DELIVERY SYSTEM FROZE ON THE CHOICE 300 ES GUIDE WIRE POST STENT DEPLOYMENT. THE GUIDE WIRE AND STENT CATHETER WERE PULLED OUT OF THE PATIENT AS A UNIT AND THE DEVICES WERE SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC CHOICE 300 ES (5PK)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR