BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 3961209 · Received July 28, 2014

    Report

    Report Number
    9681834-2014-00203
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 28, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO THE REVIEW OF INFORMATION PROVIDED BY THE USER FACILITY AND EVALUATION OF THE RETAIN SAMPLE OF THE INVOLVED LOT NUMBER AND PRODUCT CODE COMBINATION. INSPECTION AND TESTING OF A SAMPLE FROM THE REPORTED PRODUCT CODE FOUND NO DEFECTS OR ANOMALIES AND CONFIRMED THAT PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FROM THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A DEFECT OR MALFUNCTION OF THE DEVICE. THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE USER FACILITY IS MOST CONSISTENT WITH THE TRANSITION SEGMENT BETWEEN THE URETHANE LAYER AND THE METAL SHAFT CAME INTO EXCESSIVE CONTACT WITH A HARD OBJECT, RESULTING IN THE PEELING -OFF OF THE URETHANE LAYER OFF THE SHAFT. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN FILED BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE STIFF PORTION OF THE GLIDEWIRE ADVANTAGE CAME APART. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED: DURING A ROUTINE CASE, SFA ANGIO BEFORE ANY INTERVENTION THE GLIDEWIRE CONNECTION TO THE STIFF PORTION OF THE GWA CAME APART; THE WIRE DID NOT SEPARATE ALTOGETHER BUT IT DID COME APART; A PINNACLE SHEATH WAS BEING USED WITH THE WIRE; THE PROCEDURE WAS COMPLETED AND; THE PATIENT IS REPORTED DOING "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439703 RADIFOCUS GLIDEWIRE ADVANTAGE GLIDEWIRE ADVANTAGE DQX TERUMO CORPORATION, ASHITAKA NA 131219

    Patients

    Seq Age Sex Outcome Treatment
    1 PINNACLE SHEATH