BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 4063620 · Received September 5, 2014

    Report

    Report Number
    2015691-2014-02067
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED (B)(4) FOGARTY FORTIS EMBOLECTOMY CATHETER WITHOUT THE PACKAGING FOR EXAMINATION. NOTE THE CATHETER WAS RECEIVED PRE DECO WITH LIGHT BLOOD. EXAMINATION OF THE BALLOON FOUND WHAT APPEARED TO BE A BALLOON RUPTURE AND THE RUPTURE IS CIRCUMFERENTIAL AROUND THE CATHETER TIP. EXAMINATION WAS UNABLE TO DETERMINE IF THERE IS ANY MISSING LATEX. BOTH WINDINGS WERE NOT BEEN DAMAGED AND THE CATHETER BODY AND HUB WERE IN GOOD CONDITION. 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. LOT NUMBER WAS NOT PROVIDED; THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BROKE. THE BALLOON BROKE DURING AN ANIMAL STUDY ON RODENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544631 FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES PR 120804FF

    Patients

    Seq Age Sex Outcome Treatment
    1