BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8743526 · Received June 28, 2019

    Report

    Report Number
    9681834-2019-00117
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    March 12, 2019
    Report Date
    June 28, 2019
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - NOT REQUIRED FOR THE REPORTED PRODUCT CODE. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. LOT NUMBER - REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. 510(K): K926214. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE COMPLAINT FILE. THE IFU STATES: MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY. EXCESSIVE MANIPULATION OF THE GLIDEWIRE WITHOUT FLUOROSCOPIC CONFIRMATION MAY RESULT IN VESSEL PERFORATION. IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. WITH NO RETURN OF THE ACTUAL DEVICE, 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 A TMVR WAS IMPLEMENTED. THE ACTUAL RADIFOCUS GUIDEWIRE M WAS ADVANCED INTO THE LEFT ATRIUM. WHILE IT WAS BEING PLACED IN THE LEFT SUPERIOR PULMONARY VEIN, ITS DISTAL TIP JUMPED UP. WHILE THE CLIP DELIVERY SYSTEM WAS BEING STEERED, REGURGITATION WAS FOUND, AND A CARDIAC ARREST OCCURRED. AFTERWARD, DC AND PCPS WERE IMPLEMENTED. WITH VENTRICULAR FIBRILLATION NOTED, AMIODARON WAS ADMINISTERED. THE PATIENT'S VITAL SIGNS BECAME STABLE. THE CLIP WAS PLACED, AND THE PROCEDURE WAS FINISHED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MITRACLIP HAD BEEN IMPLEMENTED, AND THE PATIENT RECOVERED WITH NO ISSUE AND DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537947 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention