BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3120340 · Received May 20, 2013

    Report

    Report Number
    3008500478-2013-00431
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND ON THE CATHETER. A CRYSTALLINE WAS VISIBLE IN THE BALLOON. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WITH 2 CC SYRINGE OF WATER AND FOUND THE BALLOON WAS DIFFICULT TO INFLATE DUE TO THE OCCLUDED OF THE BALLOON LUMEN. THE RETURNED SAMPLE SHOWED NO SIGNS OF A MANUFACTURING DEFECT. THE ONLY DEFECT FOUND WAS THE OCCLUSION IN THE BALLOON LUMEN CAUSED BY A CRYSTALLINE MATERIAL. THERE IS NO PROCESS DURING PRODUCTION OF PROPLEGE DEVICES THAT COULD CREATE OR CAUSE THIS CRYSTALLINE MATERIAL TO FORM. A MANUFACTURING DEFECT IS NOT CONFIRMED. IT IS MOST LIKELY THAT CLINICIAN ERROR CAUSED THIS REPORTED DEFLATION DIFFICULTY. USING 1:4 RATION OF CONTRAST SOLUTION TO FILL THE BALLOON DOES NOT FOLLOW IFU REQUIREMENTS. THE PROPLEGE DEVICE WAS NOT DESIGNED TO BE ABLE TO USE 1:4 RATIO OF CONTRAST SOLUTION IN THE BALLOON LUMEN CONSISTENTLY. THE ROOT CAUSE OF THE REPORTED BALLOON DEFLATION DIFFICULTY IS USER ERROR ¿ FAILURE TO FOLLOW IFU. 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. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO NONCONFORMANCES WITH THIS DEVICE. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED : "A PROCEDURE WAS PERFORMED ON (B)(6) 2013, AND THE ANESTHESIOLOGIST WAS IN CHARGE OF PLACING THE PROPLEGE CORONARY SINUS CATHETER. WHILE PREPPING THE PRODUCT, THE ANESTHESIOLOGIST USED PURE CONTRAST TO INFLATE THE BALLOON TO DE-AIR AND VERIFY THE BALLOON INTEGRITY. HE WAS NOT ABLE TO DEFLATE THE BALLOON ONCE INFLATED AS THE LUMEN SEEMED TO BE CLOGGED BY THE CONTRAST. THEY DECIDED NOT TO USE THIS CATHETER AND CHANGED FOR ANOTHER PR9." THE CUSTOMER STATED TO ALWAYS USES A 1:4 CONTRAST DILUTION RATIO, DESPITE KNOWING THE INSTRUCTIONS FOR USE INDICATES 1:6. THE CUSTOMER ALSO USED THIS 1:4 WITH THE REPLACEMENT DEVICE AND NO COMPLICATIONS WERE NOTED. NO EDWARDS PERSONNEL WERE PRESENT AT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222368 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59479664

    Patients

    Seq Age Sex Outcome Treatment
    1