BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE AORTIC DEVICE

    MDR report key: 3241702 · Received July 22, 2013

    Report

    Report Number
    3008500478-2013-00480
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 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

    THE DEVICE EVALUATION IS ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND A KINK WAS FOUND JUST BELOW THE TRIFURCATION HUB OF THE CATHETER. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON AND TWO SMALL PIN HOLES WERE FOUND ON THE BALLOON. THE REPORTED PIN HOLES IN THE BALLOON CAN HAVE MULTIPLE POSSIBLE ROOT CAUSES. MANUFACTURING RECORDS WERE REVIEWED AND NO INDICATIONS FOR A MANUFACTURING DEFECT WERE FOUND FOR THIS LOT. THESE PIN HOLES WERE NOT DETECTED DURING THE PREPARATION OF THE DEVICE BEFORE USE. IT IS HIGHLY UNLIKELY THAT THE REPORTED EVENT WAS CAUSED DURING THE MANUFACTURING PROCESS. FROM REVIEWING THE COMPLAINT THE PIN HOLES IN THE BALLOON WERE MOST LIKELY NOT PRESENT DURING THE PREPARATION OF THE DEVICE. A NEEDLE STICK TO AN INFLATED BALLOON MOST LIKELY WOULD CAUSE THE BALLOON TO BURST AND NOT HAVE TWO PIN HOLES. THE PIN HOLES IN THE BALLOON CANNOT BE DETERMINED. THE INFORMATION GATHERED DURING THIS REPORTED EVENT AND EVALUATION WILL BE INCLUDED IN TRENDING DATA FOR FUTURE CAPA DETERMINATIONS. THE IFU CONTAINS THE APPROPRIATE INSTRUCTIONS ON HOW TO USE THE DEVICE SAFELY. A CAPA AND PRA WILL NOT BE INITIATED FOR THIS COMPLANT. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THAT THE INTRACLUDE AORTIC DEVICE, ICF100 BALLOON FAILED DUE TO A BELIEVED NEEDLE STICK AFTER PLACEMENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340845 INTRACLUDE AORTIC DEVICE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100

    Patients

    Seq Age Sex Outcome Treatment
    1