BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3840551 · Received May 30, 2014

    Report

    Report Number
    3008500478-2014-00075
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO DEFECTS OR KINKS. VISUAL INSPECTION OF THE BALLOON FOUND AN UNKNOWN SUBSTANCE INSIDE OF THE BALLOON. AIR AND WATER WERE BOTH USED TO ATTEMPT TO INFLATE THE BALLOON AND WERE UNSUCCESSFUL. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THIS COMPLAINT IS UNABLE TO BE CONFIRMED. HOWEVER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO PREP THE BALLOON PROPERLY. CRYSTALLIZATION WAS FOUND INSIDE THE BALLOON. CRYSTALLIZATION IS KNOWN TO OCCUR WITH CONTRASTING AGENT AND IS NOT TYPICAL WHEN USED WITH PHYSIOLOGICAL STERILE SOLUTION ONLY. PER THE IFU THE BALLOON IS TO BE PREPPED WITH PHYSIOLOGICAL STERILE SOLUTION. IT IS NOT LIKELY THAT HEAVY CRYSTALLIZATION AS SEEN IN THE RETURNED UNIT WOULD HAVE FORMED WITH THE USE OF PHYSIOLOGICAL STERILE SOLUTION. IT IS LIKELY THAT THE BALLOON WAS NOT PREPPED ACCORDING TO THE IFU. TRENDS FOR THIS ISSUE ARE IN CONTROL AND WILL CONTINUE TO BE MONITORED. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NCR'S FOUND. THERE WILL BE NO PRA OR CAPA INITIATED AT THIS TIME. THE INSTRUCTIONS FOR USE, TRAINING AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING THE PREP OF A PROPLEGE CORONARY SINUS CATHETER, PR9 THE BALLOON WOULD NOT INFLATE AND DEFLATE CORRECTLY. A NEW DEVICE HAD TO BE OPENED AND USED. NO REPORTED PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318841 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59708053

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR