BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2880016 · Received December 19, 2012

    Report

    Report Number
    3008500478-2012-00346
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    February 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE INTRODUCER WAS VISUALLY INSPECTED AND THE LEAKING WAS CONFIRMED. A TEAR WAS FOUND ON THE HEMOSTASIS VALVE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. A CAPA HAS BEEN INITIATED IN REGARD TO THE INTRORC LEAKING COMPLAINTS. INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND APPROPRIATE. A REVIEW OF MANUFACTURING RECORDS FOR THIS LOT WAS PERFORMED. (B)(4). TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A CASE THE "NEW INTRODUCER IN THE PROPLEGE CORONARY SINUS DEVICE, PR9 WAS LEAKING BACK THROUGH THE HEMOSTATIC VALVE PRIOR TO THE DEVICE BEING PLACED THROUGH IT." THE DEVICE WAS PLACED WITHOUT INCIDENT AND WORKED FINE DURING THE CASE, HOWEVER, WHEN REMOVED THE VALVE WAS FAILING TO REMAIN HEMOSTATIC. THERE WAS NO STATED PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59385159

    Patients

    Seq Age Sex Outcome Treatment
    1