BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE

    MDR report key: 3841629 · Received May 30, 2014

    Report

    Report Number
    3008500478-2014-00077
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS FOUND NO NON-CONFORMANCES FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    AS REPORTED AN ICF100 BURST DURING USE. THE PATIENT HAD AN AORTA WITH A DIAMETER OF 43MM. THE SURGEON STILL DECIDED TO OCCLUDE THE AORTA USING THE INTRACLUDE. TO GET TO A REASONABLE OCCLUSION WITH NO LEAKAGE, AS PER ECHO THEY SAW SOME LEAK AROUND BALLOON, THE SURGEON INFLATED THE BALLOON WITH 75 CC¿S OF SALINE, THE SURGEON WAS AWARE THAT THE MAXIMUM VOLUME WAS 40CC´S. AT THIS POINT, THE BALLOON EXPLODED IN THE PATIENT. THE CPB HAD BEEN INITIATED LESS THAN 5 MINUTES BEFORE. WHEN THIS HAPPENED, THEY IMMEDIATELY DECIDED TO CLAMP THE AORTA USING THE CHITOWOOD CLAMP. THEY KEPT THE BALLOON AND ARE SENDING IT TO EVALUATION TO SEE IF ANY OF THE BALLOON MATERIAL STAYED IN THE PATIENT. LOOKING AT THE BALLOON, THERE DOES NOT SEEM TO BE ANY MATERIAL MISSING BUT THEY STILL NEED OUR EXPERTISE TO EVALUATE THE BALLOON. THE PATIENT DOES NOT HAVE ANY COMPLICATION RELATED TO THE RUPTURE OF THE BALLOON. NO ADDITIONAL DATA WERE AVAILABLE. EVALUATION: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A RADIAL BURST TEAR IN THE BALLOON. THE COMPLAINT THAT THE BALLOON BURST WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THIS COMPLAINT IS AN APPLICATION DEFECT, AS EVIDENCED BY THE DOCTOR ACKNOWLEDGING THAT HE HAD FILLED THE BALLOON WITH 75 CC OF FLUID, AS OPPOSED TO THE MAXIMUM SPEC OF 40 CC, WHICH, ACCORDING TO CASE NOTES, HE WAS AWARE OF BUT DID NOT FOLLOW BECAUSE HE WANTED TO FINISH THE PROCEDURE. IT WAS FOUND THAT WHILE THE BALLOON RUPTURED AND STRETCHED SOMEWHAT, THERE IS NO EVIDENCE OF ANY MISSING MATERIAL. TRENDS FOR THIS ISSUE ARE IN CONTROL AND WILL CONTINUE TO BE MONITORED. MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED DUE TO NO LOT NUMBER PROVIDED BY THE CUSTOMER. 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

    AS REPORTED BY OUR COLLEAGUES IN EUROPE AN INTRACLUDE AORTIC DEVICE, ICF100 BURST DURING USE. THE PATIENT HAD AN AORTA WITH A DIAMETER OF 43MM. THE SURGEON STILL DECIDED TO OCCLUDE THE AORTA USING THE INTRACLUDE. TO GET TO A REASONABLE OCCLUSION WITH NO LEAKAGE, THE SURGEON INFLATED THE BALLOON WITH 75 CC'S OF SALINE. AT THIS POINT, THE BALLOON EXPLODED IN THE PATIENT. THE CPB HAD BEEN INITIATED LESS THAN 5 MINUTES BEFORE. WHEN THIS HAPPENED, THEY IMMEDIATELY DECIDED TO CLAMP THE AORTA USING THE CHITOWOOD CLAMP. THEY KEPT THE BALLOON AND ARE SENDING IT TO EVALUATION TO SEE IF ANY OF THE BALLOON MATERIAL STAYED IN THE PATIENT. LOOKING AT THE BALLOON, THERE DOES NOT SEEM TO BE ANY MATERIAL MISSING BUT THEY STILL NEED OUR EXPERTISE TO EVALUATE THE BALLOON. TWENTY FOUR HOURS POST-PROCEDURE, THE PATIENT DOES NOT HAVE ANY COMPLICATION RELATED TO THE RUPTURE OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318053 INTRACLUDE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100 59435975

    Patients

    Seq Age Sex Outcome Treatment
    1