BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2122168 · Received June 13, 2011

    Report

    Report Number
    2015691-2011-15709
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EMBOLECTOMY CATHETER WAS RETURNED WITHOUT THE PACKAGING FOR EVALUATION. THE REPORTED CUSTOMER COMPLAINT OF "BALLOON OBSERVED BROKEN" WAS CONFIRMED. THE EVALUATION INCLUDED A VISUAL EXAMINE, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY. THE DISTAL WINDINGS HAVE BEEN PULLED OFF THE DISTAL TIP OF THE CATHETER TIP. THE DISTAL WINDINGS WERE NOT RETURNED AND THERE APPEARS TO BE LATEX MISSING. THIS CONDITION MAY OCCUR WHEN THE PULL FORCE OF 1.5 LBS (PER IFU) HAS BEEN EXCEEDED. THE CATHETER BODY WAS EXAMINED AND FOUND TO BE IN GOOD CONDITION. ALTHOUGH THE REPORTED CUSTOMER COMMENT "BALLOON OBSERVED BROKEN" WAS CONFIRMED, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. COMPLAINTS OF THIS TYPE WERE PREVIOUSLY INVESTIGATED AND IT WAS DETERMINED THAT ALTHOUGH PROCEDURAL FACTORS CONTRIBUTE SIGNIFICANTLY TO THIS TYPE OF FAILURE, ACTIONS WOULD BE IMPLEMENTED TO REINFORCE THE MANUFACTURING PRACTICES DURING THE WINDING PROCESS. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS NOTED TO BE BROKEN DURING THE REMOVAL FROM THE ARTERY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120804F 58852018

    Patients

    Seq Age Sex Outcome Treatment
    1