BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY II CATHETER

    MDR report key: 2190809 · Received August 4, 2011

    Report

    Report Number
    2015691-2011-15983
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K901625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION; HOWEVER, IF ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REVIEW OF THE LIMITED INFORMATION AVAILABLE SUGGESTS THAT PROCEDURAL FACTORS AND/OR CHARACTERISTICS OF THE VASCULATURE MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    RECEIVED ADHERENT CLOT CATHETER WITHOUT THE PACKAGING. VISUAL EXAMINATION WAS PERFORMED ON THE CATHETER BODY, TIP AND HANDLE AND THERE WAS DAMAGE TO THE CATHETER TIP OBSERVED. THERE APPEARS TO BE A SECTION OF THE CATHETER TIP BROKEN OFF AND IT WAS NOT RETURNED. THERE IS ALSO A SECTION OF THE LATEX COVER TORN OFF THE COIL COVER AND ALSO WAS NOT RETURNED. FURTHER EXAMINATION OF THE CATHETER TIP FOUND THAT THERE IS ABOUT A 15MM SECTION OF THE TIP THAT HAS BROKEN OFF AND WAS NOT RETURNED WITH THE REST OF THE CATHETER. THERE ALSO APPEARS TO BE A SMALL SECTION OF THE LATEX MISSING; HOWEVER, IT IS NOT POSSIBLE TO DETERMINE JUST HOW MUCH IS MISSING DUE TO THE STRETCHED CONDITION OF THE LATEX. THERE WAS NO DAMAGE OBSERVED ON THE REST OF THE CATHETER BODY OR COILS UNDER THE LATEX COVER. THERE WAS NO INDICATION OF A MANUFACTURING DEFECT FOUND DURING THE EVALUATION. AS NOTED IN THE PRODUCT IFU, THE MAXIMUM PULL FORCE ON THE CONTRACTED MEMBRANE IS 1.3 LBS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE VOLUNTARY MEDWATCH RECEIVED FROM A CUSTOMER ORIGINALLY REPORTED THAT A PATIENT WAS UNDERGOING THROMBECTOMY AND REVISION OF HIS RIGHT UPPER EXTREMITY ARTERIOVENOUS GRAFT. THE CATHETER BECAME WEDGED AND THE PROCEDURALIST WAS UNABLE TO REMOVE IT FROM THE DISTAL GRAFT AREA. THE CATHETER WIRE WAS SUBSEQUENTLY REMOVED WITH THE EXCEPTION OF A SMALL RUBBER TIP. THERE WAS GOOD FLOW IN THE GRAFT AT THE END OF THE PROCEDURE. FOLLOW UP WITH CUSTOMER INDICATED THAT THE VERY, VERY TIP (APPROXIMATELY 1CM) WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE TIP BECAUSE A CHEST X-RAY SHOWED THAT THE TIP WAS LODGED AND EMBOLIZATION WAS NOT ANTICIPATED. THE CATHETER WAS USED FOR A DECLOTTING OF A DIALYSIS GRAFT, THE PATIENT HAD NUMEROUS "ISSUES", NO ALTERNATIVE SITES FOR NEW GRAFT PLACEMENT WERE AVAILABLE. THE CATHETER WAS ADVANCED UP TO THE CEPHALIC VEIN AND REMOVED A CLOT SUCCESSFULLY. THE DIFFICULTY OCCURRED WHEN THE CATHETER WAS TURNED TO THE DISTAL END OF THE GRAFT DURING AN ATTEMPT TO REMOVE THE CLOT. AT THIS TIME, THE BALLOON COULD NOT BE DEPLOYED AND THE REMOVAL DIFFICULTY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY II CATHETER FOGARTY ADHERENT CLOT CATHETER DXE EDWARDS LIFESCIENCES, PR 140806 58884701

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR