BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 5500132 · Received March 15, 2016

    Report

    Report Number
    9681834-2016-00041
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    February 15, 2016
    Report Date
    March 15, 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 NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE INVOLVED LOT NUMBER IS UNKNOWN. THEREFORE, THE INVESTIGATION WAS BASED ON THE EVALUATION OF USER FACILITY INFORMATION AND EVALUATION OF A CURRENT PRODUCT SAMPLE FROM THE REPORTED PRODUCT CODE (RF-GA35153, LOT# 160125). VISUAL INSPECTION REVEALED NO DEFECTS. MAGNIFYING INSPECTION OF THE OUTER SURFACE REVEALED NO DEFECTS. THE OUTSIDE DIAMETER WAS MEASURED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATION. THE URETHANE COATING WAS REMOVED INTENTIONALLY TO CHECK THE STATE OF ADHESION OF THE URETHANE COATING TO THE CORE WIRE AND CONFIRMED TO MEET MANUFACTURER SPECIFICATION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION OR COMPLAINT RECORDS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE COMPLAINT DESCRIPTION, IT IS LIKELY THAT THE URETHANE COATING WAS SHEARED BY THE METALLIC NEEDLE USED IN COMBINATION WITH THE ACTUAL SAMPLE DURING THE PROCEDURE. 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 USE THE GUIDE WIRE M WITH DEVICES WHICH CONTAIN METAL PARTS SUCH AS ATHERECTOMY CATHETERS, LASER CATHETER, OR METAL INTRODUCTION DEVICES AS THEY MAY CAUSE THE GUIDE WIRE M PLASTIC COATING TO SHEAR AND/OR SEVER THE WIRE." 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: AFTER A PUNCTURE WITH A COMPETITOR'S METALLIC NEEDLE, THE ACTUAL SAMPLE WAS INSERTED THROUGH THE NEEDLE. THE DOCTOR THEN ACCIDENTALLY PULLED THE ACTUAL SAMPLE IN THE PROXIMAL DIRECTION, IT WAS THEN, WHEN THE URETHANE COATING ON THE ACTUAL SAMPLE WAS SHEARED BY THE NEEDLE BY APPROXIMATELY 3MM. IT WAS REPORTED THE SHEARED URETHANE SEGMENT SEEMED TO REMAIN IN THE BILIARY DUCT. DUE TO THE OCCURRENCE OF THIS INCIDENT, THE DOCTOR DECIDED TO DISCONTINUE THE PLANNED DRAINAGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158829 RADIFOCUS GUIDEWIRE M CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other