BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 7137517 · Received December 21, 2017

    Report

    Report Number
    2183870-2017-00607
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 1, 2017
    Report Date
    March 9, 2018
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    10884521058057
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE CLOSUREFAST CATHETER WAS RETURNED FOR ANALYSIS NO ANCILLARY DEVICES OR PROCEDURE NOTES WERE RETURNED. VISUAL INSPECTION OF THE CATHETER REVEALED KINKING AND A MELTED FEP ON THE CATHETER COIL AREA. THERE WERE NO ISSUES NOTED ON THE DISTAL FRONT HALF OF THE COIL AREA OF THE CATHETER. DURING MICROSCOPIC OBSERVATION OF THE KINKING ON THE COIL SHAFT, AN UNKNOWN RESIDUE AND COIL/FEP MELT CAUSING COIL DAMAGE WAS OBSERVED. THE COIL DID NOT APPEAR TO HAVE BEEN EXPOSED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IMAGE RECEIVED FROM CUSTOMER SHOW A BEND/KINK IN THE HEATING ELEMENT/COIL. THERE IS EVIDENCE OF FEP SHRINK/ MELT IN THE COIL.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT PROBLEM: CONFIRMATION HAS BEEN RECEIVED THAT THE COIL WAS MELTED; THERE WAS NO VESSEL DAMAGE; THE ERROR MESSAGE APPEARED ON THE GENERATOR AFTER THREE CYCLES; THE VESSEL DIAMETER WAS 7MM AND WAS NOT TORTUOUS OR CALCIFIED; TWO SEGMENTS OF THE VESSEL WERE TREATED; IN THE FIRST SEGMENT THE PHYSICIAN PERFORMED TWO CYCLES; THE PHYSICIAN DIDN¿T CHANGE THE GENERATOR PARAMETERS AND THERE WAS RESISTANCE REMOVING THE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST CATHETER TO TREAT A VENOUS INSUFFICIENCY IN THE GSV. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PHYSICIAN ATTEMPTED TO TREAT A SEGMENT PROXIMAL TO THE SFJ AND AN ERROR MESSAGE APPEARED ON THE GENERATOR. THE COIL PORTION OF THE CATHETER KINKED. THE PHYSICIAN USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917968 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN 10884521058057

    Patients

    Seq Age Sex Outcome Treatment
    1