BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

    MDR report key: 2760949 · Received September 26, 2012

    Report

    Report Number
    2015691-2012-18355
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WILL NOT ALLOW RETURN OF THE DEVICE FOR EVALUATION. AN EDWARDS REPRESENTATIVE WILL BE ALLOWED TO PHOTOGRAPH THE UNIT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF A BASIC VISUAL ANALYSIS CAN BE PERFORMED WITH THE PHOTOS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Additional Manufacturer Narrative · 1

    THE SALES REPRESENTATIVE WAS ALLOWED TO TAKE PHOTOGRAPHS OF THE DEVICE AND PERFORM A BASIC VISUAL EXAMINATION AT THE HOSPITAL. ADDITIONAL CLINICAL DETAILS WERE ALSO OBTAINED DURING THIS VISIT. AS DISCUSSED, THE PHYSICIAN HAD PASSED THE BALLOON INSIDE A LEG GRAFT A FEW TIMES, DETERMINING THAT IT WAS CLEAR. UPON RETRACTION FROM THE SHEATH, HE NOTICED THE BALLOON WAS MISSING AND IT WAS APPARENT THERE WAS OBSTRUCTED FLOW SO THE OTHER END OF THE GRAFT WAS CLAMPED OFF. THE PHYSICIAN STATED THAT THROUGH TESTING, IT WAS DETERMINED THAT THE END OF THE CATHETER WAS STILL IN THE PATIENT AS OF (B)(6) 2012. THE PATIENT IS "OK AND STABLE". THE PATIENT HAS A LONG HISTORY OF ACCESS OPENING TREATMENTS, END STAGE RENAL DISEASE AND STENOSIS/THROMBOSIS. THE PATIENT HAD NO ACCESS LEFT IN THEIR ARMS AND WAS HAVING DIALYSIS THROUGH A LEG GRAFT. A TEMPORARY ACCESS WAS PUT IN AT THE NECK. THE CORRECT INFLATION VOLUME WAS CONFIRMED. THE IFU WAS REVIEWED WITH THE ACCOUNT, AT THIS TIME TO REITERATE THAT THE BALLOON IS MEANT TO BE USED ON SOFT, FRESH THROMBUS AND TO SUGGEST THE ADHERENT CLOT CATHETER (ACC) AS AN ALTERNATIVE FOR CLOT REMOVAL IN THIS TYPE OF PROCEDURE. DURING THE PRODUCT EXAMINATION, IT WAS CONFIRMED THAT APPROXIMATELY 20 CM OF THE DISTAL END OF THE CATHETER WERE MISSING, INCLUDING THE BALLOON TIP. FURTHER EVALUATION OF THE PHOTOS AT THE EDWARDS FACILITY CONFIRMED THAT THE CATHETER WAS BROKEN JUST PROXIMAL OF WHERE THE 20CM MARKER WOULD BE LOCATED. THE AREA PROXIMAL OF THE BREAK SITE APPEARS TO BE ELONGATED (STRETCHED) DUE TO THE CATHETER TUBING NARROWING (NECK-DOWN) BEFORE THE BREAK SITE. THE PRODUCT IFU STATES "TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE." FOR THIS CATHETER, THE MAXIMUM INFLATION VOLUME IS 0.9 ML LIQUID AND 1.7 ML GAS. THE MAXIMUM PULL FORCE ON AN INFLATED BALLOON IS 2.0 LBS. NO OTHER OBSERVATIONS COULD BE MADE FROM THE PHOTOS RETURNED. THE COMPLAINT WAS CONFIRMED; HOWEVER, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT CLINICAL FACTORS (CHARACTERISTICS OF THE VASCULATURE) AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A PROCEDURE THE CATHETER/BALLOON "BURST". WHEN THE PHYSICIAN WAS REMOVING THE CATHETER A PIECE OF THE WAS MISSING, POSSIBLY THE TIP OF THE CATHETER/BALLOON. RETRIEVAL WAS PERFORMED; HOWEVER, IT WAS INDICATED THAT THEY COULD NOT FIND THAT THE "MISSING PIECE". THERE WERE NO PATIENT COMPLICATIONS REPORTED. FOLLOW UP INDICATED THAT THE PROCEDURE INVOLVED A GRAFT AND A NATIVE VESSEL, FEMORAL ARTERY. THE PROCEDURE SITE WAS THE LEFT LEG AND THE CATHETER WAS USED DURING A PERCUTANEOUSLY THROUGH A SHEATH. THERE WAS RESISTANCE NOTED DURING EXTRACTION; HOWEVER, IT WAS INDICATED THAT IT WAS NOTHING UNUSUAL. THE RESISTANCE WAS ATTRIBUTED TO ARTERIAL PLUG. THE CONDITION OF THE VESSEL WAS: MILDLY CALCIFIED ARTERY; ADHERENT ARTERIAL PLUG. THE INCIDENT OCCURRED DURING THE 1ST PASS EXTRACTION. THE CATHETER WAS PRETESTED AND THE CATHETER IS AVAILABLE TO BE RETURNED. FOLLOW UP INDICATED THAT THE DEVICE NEEDS TO REMAIN AT THE HOSPITAL; HOWEVER, IT IS AVAILABLE TO BE EXAMINED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 12TLW805F35 59263513

    Patients

    Seq Age Sex Outcome Treatment
    1