BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

    MDR report key: 2103335 · Received May 19, 2011

    Report

    Report Number
    2103335
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTERIO-VENOUS SHUNT DECLOT PROCEDURE, THE CATHETER'S BALLOON WAS INFLATED AND USED FOR ITS INTENDED PURPOSE. AFTER DR FINISHED PASSING THE BALLOON THROUGH THE SHUNT TO REMOVE THE CLOT, HE WENT TO DEFLATE THE BALLOON AND IT WOULD NOT DEFLATE. DR CHECKED THE FLUID RETENTION LOCK AND IT WAS OPEN. HE TRIED SEVERAL MINUTES TO DEFLATE THE BALLOON. ULTIMATELY, DR DECIDED IT WAS NECESSARY TO POP THE BALLOON TO FREE IT FROM THE PATIENT'S ARM. HE DID SO WITHOUT FURTHER COMPLICATIONS OR HARM TO THE PATIENT.======================MANUFACTURER RESPONSE FOR THRU-LUMEN EMBOLECTOMY CATHETER, FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER (PER SITE REPORTER)======================UNSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER THRU-LUMEN EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES LLC REF: 12TLW405F35 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NONE TO OUR KNOWLEDGE THAT CONTRIBUTED.