BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAXCESS 14 GUIDEWIRE (14 IN.)

    MDR report key: 12448851 · Received September 9, 2021

    Report

    Report Number
    2032493-2021-00370
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    June 9, 2020
    Report Date
    August 10, 2021
    Manufacturer
    MICROVENTION, INC
    Product Code
    MOF
    UDI-DI
    00810170012280
    PMA / PMN Number
    K133725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATION WERE REVIEWED AND NO ANOMALY RELATED TO THE EVENT WAS FOUND. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PREOPERATIVE EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA PROCEDURE, THE PHYSICIAN NOTED A BARELY VISIBLE TRANSPARENT FILAMENTOUS FRAGMENT OF APPROXIMATELY 5 CM LENGTH, ALLEGEDLY STEMMING FROM THE TRAXCESS MICROGUIDEWIRE COATING. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROGUIDEWIRE OF UNKNOWN MODEL WITHOUT ANY DIFFICULTIES. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347119 TRAXCESS 14 GUIDEWIRE (14 IN.) CATHETER, GUIDE WIRE MOF MICROVENTION, INC GW1420040 200218 00810170012280

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening