BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 3250886 · Received July 29, 2013

    Report

    Report Number
    3008500478-2013-00486
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RELEASED BY THE HOSPITAL FOR PRODUCT EVALUATION. IF THE DEVICE IS ABLE TO BE RELEASED, THE INVESTIGATION WILL BE REOPENED INTO ROOT CAUSE OF THE ALLEGED DEFECT. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NON CONFORMANCES. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE PHYSICIAN EXPERIENCED PROBLEMS WITH THE PROPLEGE CORONARY SINUS DEVICE, PR9. THE PR9 KEPT COLLAPSING AND WOULD NOT PASS INTO THE SHEATH. THE SURGEON STATED, "I HAD BEEN TRYING TO PLACE IT BUT HEART WAS ANGLED TOWARD THE LEFT CHEST WITH THE TAKEOFF INTO THE CS AT ACUTE ANGLE TO THIS PLANE. I REPLACED THE SHEATH WITH A 12 FR SHEATH AND GOT THE CS CATH INTO THE CS.NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353301 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59490022

    Patients

    Seq Age Sex Outcome Treatment
    1