BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOLECTOMY GRN 3FR TUBE

    MDR report key: 4173382 · Received September 23, 2014

    Report

    Report Number
    4173382
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES,LLC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A 3 FR EDWARDS EMBOLECTOMY CATHETER DURING AN AORTA BIFEM. THE CATHETER BALLOON BURST WHILE HE WAS ATTEMPTING TO REMOVE CLOTS FROM THE PATIENT'S ARTERY. THIS HAS BEEN AN ONGOING PROBLEM WITH THIS ITEM FROM THIS COMPANY, ACCORDING TO THE OR STAFF. MANUFACTURER HAS BEEN NOTIFIED WITH PAST EVENTS AS WELL AS THIS EVENT. ANOTHER CATHETER HAD TO BE USED TO DE-CLOT. THERE WAS A DELAY WHILE ANOTHER CATHETER WAS OBTAINED FOR USE, BUT ULTIMATELY NO PATIENT HARM. STAFF DO NOT KNOW WHY THIS IS OCCURRING. STAFF/PHYSICIANS USING THE DEVICE ARE TRAINED AND EXPERIENCED IN USING IT. STAFF REPORT DEVICE IS BEING USED ACCORDING TO THE INSTRUCTIONS FOR USE.======================MANUFACTURER RESPONSE FOR EMBOLECTOMY CATHETER, SIZE 3 FRENCH 80 CM LENGTH EMBOLECTOMY CATHETER (PER SITE REPORTER).======================NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590985 EMBOLECTOMY GRN 3FR TUBE EBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES,LLC * F4888

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR