BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 3041975 · Received April 9, 2013

    Report

    Report Number
    9681834-2013-00036
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE FAILURE INVESTIGATION CONSISTED OF A REVIEW OF USER FACILITY INFORMATION, A RESERVE SAMPLE AND QUALITY RECORDS. THE EXAMINATION AND TESTING OF THE RESERVE SAMPLE FROM THE REPORTED LOT CONFIRMED NO EVIDENCE OF ABNORMALITIES OR DEFECTS AND PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF COMPLAINTS FOR THIS PRODUCT CODE AND LOT NUMBER COMBINATION FOUND NO SIMILAR REPORTS OF VESSEL PERFORATION FROM THE GUIDEWIRE. BASED UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT INDICATES THIS EVENT WAS RELATED TO A DEFECT OR MALFUNCTION OF THE GUIDEWIRE DEVICE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT UNDER CERTAIN CIRCUMSTANCES IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE WHICH STATES "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY. EXCESSIVE MANIPULATION OF THE GLIDEWIRE WITHOUT FLUOROSCOPIC CONFIRMATION MAY RESULT IN VESSEL PERFORATION." 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

    PER THE USER FACILITY MEDWATCH REPORT #(B)(4), WHICH WAS RECEIVED FROM THE USER FACILITY ON (B)(6) 2013: "CARDIAC CATHETERIZATION PROCEDURE WAS DONE VIA RIGHT RADIAL ARTERY APPROACH. WIRE PERFORATION WAS NOTED AT THE BRANCH OF THE RIGHT RADIAL ARTERY. PROCEDURE WAS ABORTED. NON-INVASIVE CUFF WAS PLACED ON RIGHT ELBOW FOR PRESSURE". FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147783 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 120625

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R