BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1051067 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01479
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A GUIDE WIRE COATING DETACHMENT OCCURRED. THE 99% STENOSED AND CALCIFIED LESION WAS LOCATED IN LEFT ILIAC ARTERY (LIA). ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL ARTERY AND AN UNSPECIFIED 7F LONG SHEATH AND ANOTHER MFR'S 0.035 GUIDE WIRE WERE PLACED. THE GUIDE WIRE WAS REMOVED AND THE 0.035 AMPLATZ GUIDE WIRE WAS INSERTED WITH AN UNSPECIFIED 4FR PIGTAIL ANGIOGRAPHIC CATHETER. THE ANGIOGRAPHIC CATHETER WAS REMOVED AND A WANDA 8.0MM X 4.0MM BALLOON CATHETER WAS ADVANCED ALONG THE GUIDE WIRE WITH RESISTANCE, BUT WAS ABLE TO CROSS THE LESION. THE BALLOON RUPTURED AT 10ATMS ON THE FIRST INFLATION. A SECOND WANDA 8.0MM X 4.0MM BALLOON CATHETER WAS ADVANCED ALONG THE GUIDE WIRE, HOWEVER, "STRONG" RESISTANCE WAS ENCOUNTERED AND THE BALLOON CATHETER BECAME "STUCK" ON THE GUIDE WIRE PRIOR TO REACHING THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BY APPLYING FLUSH SOLUTION WHICH ALLOWED THE BALLOON CATHETER TO BE SUCCESSFULLY REMOVED FROM THE PT. UPON REMOVAL OF THE GUIDE WIRE, IT WAS NOTED THAT APPROX 1CM OF COATING HAD COME OFF AN UNSPECIFIED LOCATION ON THE GUIDE WIRE. IT WAS PRESUMED THAT THE COATING REMAINED INSIDE THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MFR'S GUIDE WIRE. THE PT'S STATUS IS REPORTED AS "NO PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 11093419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0.035 RADIFOCUS GUIDE WIRE