BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE

    MDR report key: 3610833 · Received February 6, 2014

    Report

    Report Number
    3008500478-2014-00013
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE TO BE EVALUATED ON RECEIPT AT EDWARDS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THE INTRACLUDE (ICF100) BALLOON SUDDENLY DEFLATED AND LOST OCCLUSION DURING USE. IT WAS REPORTED "THIS WAS A REDO PATIENT WITH MULTIPLE COMPLICATIONS AND COMORBIDITIES. DUE TO THE PATIENT¿S MEDICAL ISSUES IT WAS IMPOSSIBLE TO DO A STERNOTOMY AND A RIGHT THORACOTOMY REPAIR WAS THE ONLY OPTION AVAILABLE. THIS SURGEON IS EXPERIENCED WITH OUR PLATFORM AND HAS USED THE EC AND ICF ON MULTIPLE OCCASIONS. THE DEVICE WAS PREPPED BY THE SURGICAL TECH PER THE IFU'S, THE PATIENT WAS FEMORALY CANNULATED IN STANDARD FASHION WITH AN ER23B. THE ICF WAS POSITIONED IN THE ASCENDING AORTA WITHOUT DIFFICULTY AND THE PATIENT PLACED ON BYPASS. ON TRANSESOPHAGEAL ECHO IT WAS NOTED THAT THE PATIENT HAD A MODERATE AMOUNT OF CALCIUM IN HIS ASCENDING AND DESCENDING AORTA. THE ICF WAS INFLATED PER THE IFU STARTING WITH 10CC OF VOLUME AND ADDING VOLUME IN 2CC INCREMENTS UNTIL OCCLUSION WAS ACHIEVED AT APPROXIMATELY 26CC OF VOLUME. ANTEGRADE CARDIOPLEGIA WAS DELIVERED WITH SUBSEQUENT ARREST OF THE HEART AT WHICH POINT ANTEGRADE WAS STOPPED AND RETROGRADE WAS STARTED. WHEN THE RETROGRADE WAS ALMOST COMPLETED THE SURGEON MADE HIS INCISION IN THE LEFT ATRIUM AT WHICH POINT THE BALLOON SUDDENLY DEFLATED AND LOST OCCLUSION. BECAUSE OF THE LONG NATURE OF THE PROCEDURE IT WAS DECIDED TO REMOVE THE DEFECTIVE DEVICE AND REPLACE IT WITH A NEW ONE. THE NEW ICF WAS PREPPED, PLACED AND INFLATED PER THE IFU AND THE CASE PROCEEDED NORMALLY FROM THERE WITH THE PATIENT DOING WELL. EVALUATION: THE RETURNED DEVICE WAS TESTED AND FOUND TO HAVE A PINHOLE IN THE BALLOON. THE COMPLAINT THAT THE BALLOON SUDDENLY DEFLATED AND LOST OCCLUSION WAS CONFIRMED. THE ROOT CAUSE CAN LIKELY BE ATTRIBUTED TO THE CALCIUM THAT WAS NOTED IN THE ASCENDING AND DESCENDING AORTA CAUSING OR THE SURGEON MAKING AN INCISION IN THE LEFT ATRIUM WHICH WAS RIGHT BEFORE THE LOSS OF OCCLUSION WAS NOTED. TRENDS FOR THIS ISSUE ARE IN CONTROL AND WILL CONTINUE TO BE MONITORED. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NCR'S FOUND. THERE WILL BE NO PRA OR CAPA INITIATED AT THIS TIME. THE INSTRUCTIONS FOR USE, TRAINING AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THE INTRACLUDE (ICF100) BALLOON SUDDENLY DEFLATED AND LOST OCCLUSION DURING USE. IT WAS REPORTED "THIS WAS A REDO PATIENT WITH MULTIPLE COMPLICATIONS AND COMORBIDITIES. DUE TO THE PATIENT'S MEDICAL ISSUES IT WAS IMPOSSIBLE TO DO A STERNOTOMY AND A RIGHT THORACOTOMY REPAIR WAS THE ONLY OPTION AVAILABLE. THIS SURGEON IS EXPERIENCED WITH OUR PLATFORM AND HAS USED THE EC AND ICF ON MULTIPLE OCCASIONS. . THE DEVICE WAS PREPPED BY THE SURGICAL TECH PER THE IFU'S, THE PATIENT WAS FEMORALY CANNULATED IN STANDARD FASHION WITH AN ER23B. THE ICF WAS POSITIONED IN THE ASCENDING AORTA WITHOUT DIFFICULTY AND THE PATIENT PLACED ON BYPASS. ON TRANSESOPHAGEAL ECHO IT WAS NOTED THAT THE PATIENT HAD A MODERATE AMOUNT OF CALCIUM IN HIS ASCENDING AND DESCENDING AORTA. THE ICF WAS INFLATED PER THE IFU STARTING WITH 10CC OF VOLUME AND ADDING VOLUME IN 2CC INCREMENTS UNTIL OCCLUSION WAS ACHIEVED AT APPROXIMATELY 26CC OF VOLUME. ANTEGRADE CARDIOPLEGIA WAS DELIVERED WITH SUBSEQUENT ARREST OF THE HEART AT WHICH POINT ANTEGRADE WAS STOPPED AND RETROGRADE WAS STARTED. WHEN THE RETROGRADE WAS ALMOST COMPLETED, THE SURGEON MADE HIS INCISION IN THE LEFT ATRIUM AT WHICH POINT THE BALLOON SUDDENLY DEFLATED AND LOST OCCLUSION. BECAUSE OF THE LONG NATURE OF THE PROCEDURE IT WAS DECIDED TO REMOVE THE DEFECTIVE DEVICE AND REPLACE IT WITH A NEW ONE. THE NEW ICF WAS PREPPED, PLACED AND INFLATED PER THE IFU AND THE CASE PROCEEDED NORMALLY FROM THERE WITH THE PATIENT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78292 INTRACLUDE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100 59473497

    Patients

    Seq Age Sex Outcome Treatment
    1