BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-CROSS RF CROSSING WIRE

    MDR report key: 652568 · Received December 9, 2005

    Report

    Report Number
    2031958-2005-00004
    Event Type
    Malfunction
    Date Received
    December 9, 2005
    Date of Event
    November 16, 2005
    Report Date
    December 7, 2005
    Manufacturer
    INTRALUMINAL THERAPEUTICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ILT SAFE-CROSS RF CROSSING WIRE WAS USED IN AN ATTEMPT TO CROSS AN EXTREMELY CALCIFIED TOTAL OCCLUSION OF THE ILIAC ARTERY. THE PHYSICIAN STARTED THE PROCEDURE WITH A 0.035" WIRE BUT WAS NOT ABLE TO NAVIGATE THE LESION. HE REMOVED THE 0.035" WIRE AND INSERTED A 0.014" WIRE. THE WIRE WAS INTRODUCED THROUGH A 5F GLIDE CATHETER INTO THE RIGHT FEMORAL ARTERY. WHEN THE LESION WAS REACHED MULTIPLE BURST OF RF ENERGY WERE USED BUT THE PHYSICIAN WAS NOT ABLE TO MAKE PROGRESS INTO THE LESION. AS HE TRIED TO ADVANCE THE WIRE THROUGH THE CALCIFIED LESION THE WIRE WENT SUBINTIMAL. AT THIS POINT THE PHYSICIAN REMOVED THE HUB FROM THE WIRE AND REPLACED THE GLIDE CATHETER WITH A 1.5MM BALLOON CATHETER (MFG UNKNOWN). HE NAVIGATED THE BALLOON TO THE PROXIMAL CAP OF THE LESION AND ATTEMPTED TO REPOSITION THE 0.014" WIRE BY PULLING IT BACK INTO THE CATHETER. UPON RETRACTION THE DISTAL TIP OF THE WIRE SEPERATED FROM THE BODY OF THE WIRE. THE BODY OF THE WIRE WAS DISCARDED BEFORE THE ILT REPRESENTATIVE COULD RETRIEVE IT. THE PHYSICIAN STATED THAT SINCE THE WIRE TIP WAS SUBINTIMAL IT COULD BE LEFT IN THE PATIENT WITHOUT CONCERN OF ADVERSE SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-CROSS RF CROSSING WIRE CATHETER GUIDE WIRE DQX INTRALUMINAL THERAPEUTICS, INC. G214SN1 091405

    Patients

    Seq Age Sex Outcome Treatment
    1 *