BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8363706 · Received February 22, 2019

    Report

    Report Number
    9681834-2019-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    December 28, 2018
    Report Date
    February 22, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE ACTUAL DEVICE HAD BEEN BROKEN OFF THE URETHANE OUTER LAYER, EXPOSING THE CORE WIRE ON 0MM - APPROX. 5 MM FROM THE DISTAL END OF THE DEVICE. THE TOTAL LENGTH OF THE DEVICE WAS CONFIRMED TO MEET THE SPECIFICATIONS. IT IS MOST LIKELY THERE IS NO MISSING SECTION ON THE DEVICE. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE DISTAL BROKEN SECTION OF THE URETHANE OUTER LAYER REVEALED THAT IT PRESENTED THE CONFIGURATION WHICH IMPLIED THAT THE URETHANE OUTER LAYER HAD BEEN RIPPED OFF. SOME CREASES WERE NOTED TO HAVE BEEN GENERATED AROUND THE BROKEN END. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE PROXIMAL BROKEN SECTION OF THE URETHANE OUTER LAYER REVEALED THAT IT PRESENTED THE CONFIGURATION WHICH IMPLIED THAT THE URETHANE OUTER LAYER HAD BEEN RIPPED OFF. SOME CREASES WERE NOTED TO HAVE BEEN GENERATED AROUND THE BROKEN END. THE CORE WIRE WAS NOTED TO HAVE BEEN EXPOSED AT THE BROKEN END. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL EXTREMITY OF THE EXPOSED CORE WIRE FOUND THAT THE SURFACE OF THE CUT CROSS-SECTION HAD THE EVIDENCE THAT THE CORE WIRE HAD BEEN CUT AND PROCESSED WITH THE DEDICATED MACHINE ON THE PRODUCTION FLOOR. REPRODUCTIVE TESTING WAS PERFORMED. A GUIDE WIRE SAMPLE WAS INSERTED INTO A ANGIOGRAPHIC CATHETER THROUGH THE STOPCOCK ATTACHED TO THE CATHETER'S HUB. IN THIS STATE THE STOPCOCK OF THE CATHETER'S HUB WAS TURNED AND THE GUIDE WIRE WAS WITHDRAWN FROM THE HUB. THE URETHANE OUTER LAYER OF THE GUIDE WIRE GOT RIPPED ON THE DISTAL SECTION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. IFU STATES: WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE GUIDE WIRE M, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GUIDE WIRE M. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THE STOPCOCK ATTACHED TO THE INVOLVED CATHETER'S HUB WAS MANIPULATED IN THE STATE WHERE THE ACTUAL SAMPLE WAS PLACED IN IT. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS WITHDRAWN THROUGH THE INVOLVED CATHETER, IT WAS CAUGHT IN THE STOPCOCK, WHERE EXCESSIVE PULLING FORCE WAS GENERATED, RESULTING IN THE RIPPING OF THE URETHANE OUTER LAYER OFF THE ACTUAL SAMPLE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 STOPCOCK ATTACHED TO THE INVOLVED ANGIOGRAPHIC CATHETER WAS MANIPULATED IN THE STATE OF THE ACTUAL SAMPLE BEING PLACED IN IT. THE ACTUAL SAMPLE WAS CAUGHT IN IT. SUBSEQUENTLY, WHEN IT WAS WITHDRAWN FROM THE INVOLVED CATHETER, THE URETHANE OUTER LAYER WAS RIPPED OFF THE WIRE AND FELL OUTSIDE THE INVOLVED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156398 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANGIOGRAPHIC CATHETER.