BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 5573271 · Received April 13, 2016

    Report

    Report Number
    9681834-2016-00077
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    March 2, 2016
    Report Date
    April 13, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS DISCARDED BY THE INVOLVED FACILITY. THEREFORE THE INVESTIGATION IS BASED UPON THE USER FACILITY INFORMATION AND EVALUATION OF A CURRENT PRODUCT SAMPLE (RF-GS35153, LOT # 160122). VISUAL AND MAGNIFICATION INSPECTION REVEALED NO DEFECTS. DIMENSIONAL TESTING CONFIRMED THE SAMPLE MEETS MANUFACTURER SPECIFICATION. IN ADDITION THE URETHANE LAYER WAS REMOVED FROM THE CORE WIRE INTENTIONALLY TO INSPECT THE STATE OF ADHESION OF THE URETHANE LAYER TO THE CORE WIRE AND CONFIRMED THE SAMPLE MEETS MANUFACTURER SPECIFICATION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS. THERE IS NO INDICATION THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS, WITH NO RETURN OF THE ACTUAL SAMPLE TO EVALUATE, THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : DEVICE DISCARDED BY THE FACILITY

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED SEPARATION OF THE URETHANE LAYER WHEN USING THE RF GW M DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING PTCD, THE ACTUAL DEVICE WAS USED IN COMBINATION WITH A METAL NEEDLE; THE DISTAL SEGMENT OF THE ACTUAL DEVICE WAS SEPARATED FROM THE MAIN BODY AND LEFT IN THE BILE DUCT; A CT EXAMINATION AFTER TWO WEEKS CONFIRMED IT WAS STILL THERE; IT WAS REPORTED THEY HAVE A PLAN TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228354 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R METAL NEEDLE| METAL NEEDLE