BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE

    MDR report key: 3578990 · Received January 16, 2014

    Report

    Report Number
    3008500478-2014-00007
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    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

    UPON RETURN OF DEVICE, EVALUATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THAT THE INTRACLUDE ICF100 DEVICE WAS REPORTED AS OBSTRUCTED. THE "DEVICE WAS INSERTED INTO THE ER23B AND POSITIONED IN THE ASCENDING AORTA PER THE IFU. UPON INITIAL ATTEMPT BY THE PERFUSIONIST TO RAP IT WAS APPARENT THAT THERE WAS AN OBSTRUCTION TO THE CANNULA PREVENTING ANY BACKFLOW. AFTER MULTIPLE MANIPULATIONS WITH THE CANNULA THE ICF WAS REMOVED AND THE PROBLEM WAS CORRECTED. THE ICF WAS REINSERTED INTO THE CANNULA, POSITIONED IN THE ASCENDING AORTA AND THE CASE PROCEEDED NORMALLY. WHEN REQUIRED, THE ICF WAS INFLATED WITH 35CC OF SALINE AND AORTIC OCCLUSION WAS ACHIEVED. DURING THE PROGRESSION OF THE CASE THERE WAS PERIODIC LEAKAGE AROUND THE BALLOON AND THE SURGEON DECIDED TO ADD MORE VOLUME ABOVE THE 35CC RECOMMENDED IN THE IFU. OVERALL AN ADDITIONAL 6CC WAS ADDED FOR A TOTAL OF 41CC IN THE BALLOON. AS THE ANNULOPLASTY RING WAS BEING TIED DOWN THE BALLOON SPONTANEOUSLY LOST INTEGRITY AND THEREBY OCCLUSION OF THE AORTA WAS LOST. THE REPAIR AND ATRIAL CLOSURE WERE FINISHED WITH THE HEART FIBRILLATING AND THEN BEATING AND THEN THE BALLOON WAS DEFLATED AS MUCH AS POSSIBLE. THE ICF WAS THEN REMOVED FROM THE PATIENT AND INSPECTED AT WHICH TIME THERE WAS OBSERVED A LARGE TEAR IN THE BALLOON. IT WAS DETERMINED THAT ALL OF THE EDGES LINED UP WITH EACH OTHER AND THEREFORE THERE WAS NO RISK OF AN EMBOLUS FROM ANY RESIDUAL PIECES OF THE BALLOON. THE CASE PROCEEDED AND FINISHED NORMALLY AND WITHOUT COMPLICATION." IT WAS REPORTED BY THE SALES REP FOLLOWING INVESTIGATIONAL FOLLOW UP THAT "THE BALLOON WAS INFLATED PER THE IFU STARTING WITH 10CC AND ADDING 2CC AT A TIME UNTIL OCCLUSION WAS ACHIEVED WITH A TOTAL VOLUME OF APPROXIMATELY 25CC OF SALINE. THE PRESSURE INSIDE THE BALLOON INITIALLY WAS BETWEEN 390-400MMHG AND TRENDED DOWN INTO THE LOW 300'S AS IS TYPICALLY SEEN DURING THE PROGRESSION OF THE CASE." EVALUATION: INSPECTION OF THE RETURNED DEVICE FOUND IT TO BE RUPTURED. THE BALLOON HAD A LONGITUDINAL TEAR AND A RADIAL TEAR. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS UNABLE TO BE CONFIRMED. 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 THAT THE INTRACLUDE ICF100 DEVICE WAS REPORTED AS OBSTRUCTED. THE "DEVICE WAS INSERTED INTO THE ER23B AND POSITIONED IN THE ASCENDING AORTA PER THE IFU. UPON INITIAL ATTEMPT BY THE PERFUSIONIST TO RAP, IT WAS APPARENT THAT THERE WAS AN OBSTRUCTION TO THE CANNULA PREVENTING ANY BACKFLOW. AFTER MULTIPLE MANIPULATIONS WITH THE CANNULA, THE ICF WAS REMOVED AND THE PROBLEM WAS CORRECTED. THE ICF WAS REINSERTED INTO THE CANNULA, POSITIONED IN THE ASCENDING AORTA AND THE CASE PROCEEDED NORMALLY. WHEN REQUIRED, THE ICF WAS INFLATED WITH 35CC OF SALINE AND AORTIC OCCLUSION WAS ACHIEVED. DURING THE PROGRESSION OF THE CASE, THERE WAS PERIODIC LEAKAGE AROUND THE BALLOON AND THE SURGEON DECIDED TO ADD MORE VOLUME ABOVE THE 35CC RECOMMENDED IN THE IFU. OVERALL AN ADDITIONAL 6CC WAS ADDED FOR A TOTAL OF 41CC IN THE BALLOON. AS THE ANNULOPLASTY RING WAS BEING TIED DOWN THE BALLOON SPONTANEOUSLY LOST INTEGRITY AND THEREBY OCCLUSION OF THE AORTA WAS LOST. THE REPAIR AND ATRIAL CLOSURE WERE FINISHED WITH THE HEART FIBRILLATING AND THEN BEATING AND THEN THE BALLOON WAS DEFLATED AS MUCH AS POSSIBLE. THE ICF WAS THEN REMOVED FROM THE PATIENT AND INSPECTED AT WHICH TIME THERE WAS OBSERVED A LARGE TEAR IN THE BALLOON. IT WAS DETERMINED THAT ALL OF THE EDGES LINED UP WITH EACH OTHER AND THEREFORE THERE WAS NO RISK OF AN EMBOLUS FROM ANY RESIDUAL PIECES OF THE BALLOON. THE CASE PROCEEDED AND FINISHED NORMALLY AND WITHOUT COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43709 INTRACLUDE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100 59478793

    Patients

    Seq Age Sex Outcome Treatment
    1