BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDORETURN INTRODUCER

    MDR report key: 3223037 · Received July 12, 2013

    Report

    Report Number
    3008500478-2013-00467
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMPLAINT REFERENCED MDR SUBMISSION OF INTRACLUDE AORTIC DEVICE, REPORT NUMBER 3008500478-2013-00461.: EVALUATION: THE ENDORETURN CANNULA WAS VISUALLY INSPECTED AND FOUND THE ROUNDED EDGE Y-ARM CONNECTOR WAS MISSING THE BUMP. THE ROOT CAUSE IS THAT THE SUPPLIER DID NOT HAVE THE PROPER CONTROLS IN PLACE TO ASSURE THAT THE CHANGE TO THE CORE PINS THAT MADE THE FINISHED DEVICE WERE IN PLACE. A MANUFACTURING DEFECT IS CONFIRMED WITH THE SUPPLIER. A PRODUCT RECALL WAS INITIATED AS A RESPONSE TO THE ENDORETURN INTRODUCER. IT IS IMPORTANT TO NOTE THAT THE CUSTOMER NEVER ALLEGED A PRODUCT DEFECT WITH THE ENDORETURN INTRODUCER; NO VISIBLE DEFECTS WOULD HAVE BEEN SEEN BY THE CUSTOMER. THROUGH INVESTIGATION OF THE DEVICE, THE NONCONFORMANCE WAS NOTED. THE COMPLAINT AND MDR HAS BEEN SUBMITTED UNDER THE INTRACLUDE DEVICE AS THIS PRODUCT DID NOT PERFORM AS INTENDED DUE TO THE NONCONFORMANCE OF THE ENDORETURN INTRODUCER. WITHOUT THIS NONCONFORMANCE, IT IS OUR BELIEF THE INTRACLUDE AORTIC (ICF100) DEVICE WOULD HAVE FUNCTIONED AS INTENDED. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS COMPLAINTS SYSTEM.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), THE INTRACLUDE BALLOON COULD NOT OCCLUDE THE AORTA. WHEN PUTTING IN THE INTRACLUDE INTO THE ENDORETURN, ER23B EVERYTHING WENT WELL. WHEN THE TEAM WANTED TO INFLATE THE BALLOON, IT RAPIDLY LOST VOLUME, BECAME UNSTABLE. BALLOON COULD NOT OCCLUDE THE AORTA. IT WAS NOT POSSIBLE TO INFLATE AND MAINTAIN PRESSURE. WHEN REMOVING THE BALLOON, THE MD SAW THAT THE INTRACLUDE WAS DAMAGED ON THE CATHETER. HE THINKS THAT THIS WAS CAUSED BY THE ERB23B. WHEN BALLOON WAS POSITIONED ON TTHE SIDE ARM OF THE ERB23B AND SLOWLY MOVED UP OVER THE GUIDEWIRE. HE THINKS THAT THE TRANSITION FROM THE SIDE ARM INTO THE ERB23B WAS THE CAUSE OF THE PROBLEM. THE INRACLUDE WAS DAMAGED, AND THIS CAUSED THE DAMAGE ON THE BALLOON LUMEN. THEY CONVERTED TO (B)(4). PATIENT DID NOT SUFFER DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322106 ENDORETURN INTRODUCER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES ER23 59430906

    Patients

    Seq Age Sex Outcome Treatment
    1