BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL 8FR ARTERIAL CATHETER

    MDR report key: 1659748 · Received April 15, 2010

    Report

    Report Number
    1713910-2010-00212
    Event Type
    Death
    Date Received
    April 15, 2010
    Date of Event
    August 31, 2009
    Report Date
    April 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NCP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. ALTHOUGH THE ACTUAL PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, CORRECTIVE ACTIONS WERE IMPLEMENTED FOR THIS ISSUE. IN MAY 2009 THE DIRECTIONS FOR USE (DFU) WAS UPDATED WITH CLARIFICATION ON DEVICE USAGE; OCTOBER 2009 THE PACKAGING OF THE CANNULA WAS IMPROVED WITH THE ADDITION OF A PROTECTIVE SHEATH WHICH SHIELDS THE WIRE WOUND SECTION; (B) (6) 2009- THE COLLAPSED/KINK/CRUSHED WIRE ISSUE WITHIN THE WIRE WOUND SECTION OF 8,10, & 12 PEDIATRIC FEMORAL DEVICES WAS RESOLVED BY INCORPORATING A STIFFER 300 KSI WIRE WITHIN THE CANNULA.

    Description of Event or Problem · 1

    A SURGICAL REPAIR OF A VENTRICULAR SEPTAL DEFECT (VSD) WAS PERFORMED ON A (B) (6) BABY. IT WAS A SCHEDULED SURGERY ON A STABLE PATIENT, WITH NO CO-MORBIDITIES. ACCORDING TO THE SURGEON, THE PROCEDURE STARTED AROUND 8:00 AM. HE USED AN EDWARDS RESEARCH MEDICAL - (B) (4) TO CANNULATE THE ASCENDING AORTA. SOON AFTER THE PATIENT WAS ON CARDIO PULMONARY BYPASS (CPB), AND THE AORTA WAS ALREADY CLAMPED, THE PERFUSIONIST MENTIONED THAT HE STARTED TO REGISTER ELEVATED AORTIC PERFUSION PRESSURES. SEVERAL MINUTES LATER, HE FOUND THAT THE CANNULA WAS ANGLED AND COLLAPSED. SHORTLY AFTER, THE TEAM DECIDED TO PUT THE PATIENT INTO DEEP HYPOTHERMIA AND PROCEEDED TO CHANGE THE ARTERIAL CANNULA AND CONTINUE WITH THE VSD REPAIR. AFTER THE VSD REPAIR WAS COMPLETED, THEY HAD DIFFICULTY GETTING THE PATIENT OFF CPB. THE TEAM KEPT TRYING TO BALANCE THE PATIENT¿S HEMODYNAMICS WITHOUT SUCCESS. AFTER SEVERAL HOURS, THEY DECIDED TO PUT THE PATIENT ON ECMO. THE PATIENT WAS OUT OF THE OPERATING ROOM AT 5:00 PM. THE PATIENT LASTED ON ECMO TEN DAYS WITH NO RELIEF DURING THAT PERIOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA COMPRESSED, AND THERE WAS AN INJURY TO THE PATIENT OF CARDIAC DISTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL 8FR ARTERIAL CATHETER NCP EDWARDS LIFESCIENCES FEMII008A

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death