BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 5479657 · Received March 4, 2016

    Report

    Report Number
    9681834-2016-00027
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 4, 2016
    Report Date
    March 4, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY A SHEARED PIECE FROM THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE SHEARED PIECE MEASURED APPROXIMATELY 120MM. MAGNIFYING INSPECTION FOUND IT HAD A SEMI CIRCULAR GROOVE ON THE SURFACE ALONG THE TOTAL LENGTH, WITH ONE END HAVING A SHEAR CROSS-SECTION PRESENTING A SMOOTH SURFACE. FUNCTIONAL TESTING WAS CONDUCTED AND WAS ABLE TO REPRODUCE THE REPORTED DEFECT. THIS TEST WAS CONDUCTED ON A CURRENT PRODUCT SAMPLE AND WAS INSERTED INTO A METALLIC MATERIAL AND WITHDRAWN FROM IT. THE URETHANE COATING WAS SHEARED FROM THE PRODUCT SAMPLE. THE SHEARED CROSS-SECTION SURFACE OF THE URETHANE COATING WAS OBSERVED TO BE SIMILAR TO THAT OF THE ACTUAL SAMPLE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION FINDINGS, IT IS LIKELY THAT THE ACTUAL SAMPLE CAME INTO CONTACT WITH A SHARP OBJECT, RESULTING IN THE SHEARING OF THE URETHANE LAYER. FROM THE AVAILABLE INFORMATION, THE DEFINITIVE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE IFU OF THIS PRODUCT DOES HAVE THE STATEMENT IN THE WARNINGS SECTION. "DO NOT MANIPULATE/WITHDRAW THE GUIDEWIRE M THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED SEPARATION OF URETHANE LAYER ON THE RADIFOCUS GUIDEWIRE M DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: (1) DURING A PROCEDURE WITH A COMPETITOR'S CV PORT, THE URETHANE LAYER SHEARED OFF THE ACTUAL SAMPLE; (2) THE SHEARED PIECE WAS RETRIEVED; (3) THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND (4) THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136359 RADIFOCUS GUIDEWIRE M CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 150923

    Patients

    Seq Age Sex Outcome Treatment
    1