BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3200459 · Received July 1, 2013

    Report

    Report Number
    3008500478-2013-00457
    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 DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE CONFIRMED, AND NO LABELING INADEQUACIES WERE IDENTIFIED. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT OCCURRENCE RATE EXCEEDS CONTROL LIMITS FOR THIS FAILURE MODE.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 EDWARDS QUALITY MANAGMENT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT WHILE THE HOSPITAL WAS PREPPING THE PROPLEGE CORONARY SINUS CATHETER, PR9 CATHETER, THEY WERE "HAVING GREAT DIFFICULTY INFLATING THE BALLOON." THEY OPTED TO OPEN A SECOND PR9 TO PROCEED WITH THE PROCEDURE. THE CATHETER WAS NEVER USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298867 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1