BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1032196 · Received April 17, 2008

    Report

    Report Number
    9681834-2008-00008
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 1, 2008
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETURNED BY THE USER FACILITY AND THE LOT NUMBER IS NOT KNOWN. THEREFORE, THE INVESTIGATION WAS CONDUCTED BASED UPON A REVIEW OF INFO PROVIDED BY THE USER FACILITY. THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THE USER FACILITY WAS NOT ABLE TO CONFIRM EITHER THE PRODUCT OR LOT NUMBER OF THE INVOLVED DEVICE, WHICH LIMITS QUALITY RECORD REVIEW. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EVENT DESCRIPTION IS CONSISTENT WITH DAMAGE TO THE GLIDEWIRE'S COATING DUE TO INCORRECT USER TECHNIQUE INVOLVING MANIPULATION OF GUIDEWIRE AGAINST A SHARP SURFACE, SUCH AS ALONG THE BEVEL OF THE METAL ENTRY NEEDLE THAT WAS USED DURING THE PROCEDURE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS/PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR - USE, WHICH STATES, " DO NOT MANIPULATE/ WITHDRAW THE GLIDEWIRE THROUGH A METAL NEEDLE/METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL NEEDLE/METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL." ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PART OF THE GUIDEWIRE WAS SHEARED OFF INSIDE THE PT WHEN THE PHYSICIAN WAS PULLING THE GUIDEWIRE BACK THROUGH A METAL ENTRY NEEDLE. THE PT WAS TAKEN TO SURGERY WHERE A CUT DOWN PROCEDURE WAS PERFORMED AND THE DETACHED MATERIAL WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SINGEL WALL ENTRY NEEDLE