BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVCIE

    MDR report key: 2962237 · Received February 14, 2013

    Report

    Report Number
    3008500478-2013-00388
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INTO ROOT CAUSE EXPECTED UPON RETURN OF THE DEVICE FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    EVALUATION: THE RETURNED INTRORC INTRODUCER WAS FOUND TO HAVE A TEAR IN THE VALVE OF THE INTRODUCER. THIS TORN VALVE MOST LIKELY CONTRIBUTED THE ISSUES EXPERIENCED IN THIS REPORT AS HAS BEEN ESTABLISHED BY THE AMOUNT OF SIMILAR COMPLAINT RECEIVED FOR LEAKING INTRORC INTRODUCERS WITH TEARS IN THE INTRODUCER VALVE. THE BEND NOTICED IN THE CATHETER WAS NOT REPORTED AND DID NOT AFFECT THE FUNCTION OF THE DEVICE. IT IS LIKELY THAT THIS OCCURRED DURING REMOVAL OF THE DEVICE. A CORRECTIVE ACTION AND PRODUCT RECALL HAVE BEEN INITIATED FOR THIS COMPLAINT. THE PROPLEGE DEVICE HAS NOW BEEN SWITCHED BACK TO BEING KITTED WITH THE INTROCSC INTRODUCER. THE ROOT CAUSE OF THE LEAKING HAS BEEN DETERMINED TO BE A MATERIAL RELAXATION ISSUE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT WHEN THE PROPLEGE CORONARY SINUS DEVICE, PR9 IS PULLED FROM THE SHEATH AND THE SHEATH IS CAPPED, THERE WAS LEAKAGE AROUND THE CAP AND THE SHEATH WAS REMOVED FROM THE PATIENT. NO PT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64784 PROPLEGE CORONARY SINUS DEVCIE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59385204

    Patients

    Seq Age Sex Outcome Treatment
    1