BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3200411 · Received July 1, 2013

    Report

    Report Number
    3008500478-2013-00456
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED BALLOON DEFLATION DIFFICULTY IS INDETERMINABLE. IT IS MOST LIKELY THAT PROCEDURAL FACTORS CAUSED THIS REPORTED DEFLATION DIFFICULTY. USING A CONTRAST SOLUTION WITH A MORE CONCENTRATED RATIO THAN 1:6 CAN CAUSE CRYSTALLINE MATERIAL TO DEPOSIT IN THE BALLOON INFLATION LUMEN. THE PROPLEGE DEVICE WAS NOT DESIGNED OR VALIDATED TO BE ABLE TO USE ANY RATIO OF CONTRAST SOLUTION OTHER THAN 1:6 IN THE BALLOON LUMEN CONSISTENTLY. 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. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING PREP THEY INFLATED THE PROPLEGE CORONARY SINUS CATHETER, PR9 BALLOON FOR DE-AIRING PURPOSES AND THE BALLOON WOULD NOT DEFLATE. THE BALLOON WAS INFLATED PER THE INSTRUCTIONS FOR USE. THE CATHETER WAS NOT USED ON A PATIENT. ANOTHER CATHETER WAS OPENED AND FUNCTIONED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298764 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59523474

    Patients

    Seq Age Sex Outcome Treatment
    1