BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8110151 · Received November 28, 2018

    Report

    Report Number
    9681834-2018-00205
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    October 31, 2018
    Report Date
    November 28, 2018
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 H6: PATIENT CODE: 3191: A FRACTURED SEGMENT OF THE ACTUAL DEVICE WAS IN THE PATIENT; HOWEVER, IT WAS SURGICALLY REMOVED. THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED AT APPROXIMATELY 200 MM FROM THE DISTAL END OF THE DEVICE. THERE WERE NO OTHER ANOMALIES, INCLUDING A KINK OR SHEARED URETHANE, ON THE REMAINDERS OF THE DEVICE. THE ACTUAL SAMPLE WAS MEASURED AS FOLLOWS. THE DISTAL SEGMENT: APPROXIMATELY 200MM. THE MAIN BODY: APPROXIMATELY. 600MM. THE TOTAL LENGTH OF THE ACTUAL DEVICE WAS CONFIRMED TO BE APPROXIMATELY 800MM. TOTAL LENGTH OF THE NORMAL PRODUCT OF THIS PRODUCT CODE IS SPECIFIED TO BE APPROXIMATELY 800MM. BASED ON THE MEASUREMENTS IT IS LIKELY THAT THE ACTUAL DEVICE DOES NOT HAVE ANY PORTION MISSING FROM THE ACTUAL DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE IFU STATES: " IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND DETERMINE THE CAUSE BY FLUOROSCOPY AND/OR ENDOSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GUIDEWIRE M NON-VASCULAR OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, OR IN PERFORATION OR TRAUMA OF THE LININGS OR ASSOCIATED TISSUES, CHANNELS OR DUCTS." THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE ACTUAL DEVICE WAS SUBJECTED TO PULLING FORCE IN THE STATE OF BEING FORMED INTO A LOOP SHAPE AND BECAME FRACTURED. DUE TO THE ACTUAL DEVICE HAVING BEEN INFECTIOUS ITS INSPECTION WAS LIMITED AND THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M DEVICE BECAME FRACTURED DURING A THORACIC DRAINAGE PROCEDURE WITH THE USE OF A TROCAR ASPIRATION KIT. THE DISTAL SECTION OF THE ACTUAL SAMPLE FORMED INTO A LOOP-LIKE SHAPE, AND WHEN THE ACTUAL SAMPLE WAS WITHDRAWN, IT BECAME FRACTURED IN THE THORAX AND REMAINED THERE. THE FRACTURED PIECE WAS SURGICALLY EXTRACTED. IT WAS REPORTED THAT THE PATIENT HAS NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950008 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TROCAR ASPIRATION KIT (COVIDIEN (B)(4))| TROCAR ASPIRATION KIT (COVIDIEN (B)(4))