BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 3932176 · Received July 14, 2014

    Report

    Report Number
    2015691-2014-01581
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLECTOMY CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE PACKAGING. AS RECEIVED THE CATHETER TIP APPEARED DAMAGED. THE BALLOON AND BALLOON WINDINGS APPEARED TO HAVE BEEN PULLED OFF THE CATHETER TIP. THE BALLOON LATEX AND BOTH PROXIMAL AND DISTAL WINDINGS WERE NOT RETURNED. AS STATED IN THE IFU, BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN ANY EMBOLECTOMY PROCEDURE. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR EACH SIZE CATHETER. PER THE IFU THE MAXIMUM PULL FORCE FOR THIS CATHETER IS 1.5 LBS ON A INFLATED BALLOON. VISUAL EXAMINATION WAS PERFORMED WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE BALLOON GOT RUPTURED DURING THROMBECTOMY AT LEG VEIN. THE PATIENT WAS WITH ATHEROSCLEROSIS. THE CLOT WAS ADHERENT, THEY WERE REMOVED WITH A CATHETER FOR ADHERENT CLOT AFTER THE PROBLEM HAD OCCURRED. ALTHOUGH THE CUSTOMER TRIED TO REMOVE THE BALLOON FRAGMENTS IN THE PERIPHERAL VESSEL AS WELL AS THE CENTRAL VESSEL, IT WAS UNABLE TO COLLECT ALL THE FRAGMENTS. THE CUSTOMER COMMENTED THAT THEY MAY HAVE MANIPULATED THE CATHETER ROUGHLY FOR THE ADHERENT CLOTS.¿ THE REMOVED FRAGMENTS WERE DISCARDED AT THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409140 FOGARTY ARTERIAL EMBOLECTOMY CATHETER FOGARTY ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120404F 59586773

    Patients

    Seq Age Sex Outcome Treatment
    1