BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2142715 · Received June 17, 2011

    Report

    Report Number
    9681834-2011-00027
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: BASED UPON USER FACILITY INFORMATION AND THE RETURNED SAMPLE. BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURN SAMPLE. THE INVOLVED SAMPLE WAS RETURNED FOR EVALUATION BY THE MANUFACTURING FACILITY. EXAMINATION OF THE RETURNED SAMPLE CONFIRMED THAT THE URETHANE COATING HAD BEEN SHEARED OFF AND DETACHED FROM THE CORE WIRE STARTING APPROXIMATELY 135MM FROM THE DISTAL END FOR A DISTANCE OF APPROXIMATELY 55MM. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURN SAMPLE ARE MOST CONSISTENT WITH DAMAGE TO THE GLIDEWIRE'S POLYURETHANE COATING DUE TO MANIPULATION OF THE GUIDEWIRE AGAINST A SHARP SURFACE, SUCH AS THE BEVEL OF THE METAL INTRODUCER NEEDLE DURING WITHDRAWAL. EXAMINATION AND TESTING OF UNDAMAGED SECTIONS OF THE WIRE CONFIRMED THERE WERE NO INDICATIONS OF MALFUNCTION OR PRE-EXISTING DEFECT. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE GUIDEWIRE WAS SHEARED OFF DURING A PORTA CATH INSERTION PROCEDURE. FOLLOW-UP COMMUNICATION CONFIRMED THAT A METAL INTRODUCER NEEDLE HAD BEEN USED IN COMBINATION WITH THE GLIDEWIRE AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER GUIDEWIRE OF THE SAME TYPE. NO ADDITIONAL EVENT SPECIFIC INFORMATION WAS ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 101201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK METAL INTRODUCER NEEDLE