BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2920352 · Received January 17, 2013

    Report

    Report Number
    3008500478-2013-00370
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE, A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, ANY MANUFACTURING DEFECT WITH THE DEVICE CANNOT BE ASSESSED. HOWEVER, IT IS LIKELY THAT THE ROOT CAUSE OF THE INTRODUCER LEAKING IS RELATED TO THE ROOT CAUSE ATTRIBUTED TO SIMILAR COMPLAINTS RECEIVED FOR THE INTRORC LEAKING THAT HAVE BEEN CONFIRMED. 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. THE LOT NUMBER OF THE DEVICE IN THIS CASE IS UNKNOWN; THEREFORE, AN DHR REVIEW WILL NOT BE CONDUCTED. THE EDWARD'S TRENDING SYSTEM INDICATES THAT THE COMPLAINTS PER MILLION (CPM) 3 SIGMA THRESHOLD FOR LEAKING INTRODUCERS HAS BEEN EXCEEDED IN DECEMBER. A PRODUCT RECALL HAS BEEN INITIATED. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT BLOOD WAS LEAKING FROM THE INTRODUCER SHEATH ON THE PROPLEGE CORONARY SINUS CATHETER, PR9. IT IS LEAKING BETWEEN THE INTRODUCER AND THE LOCKING STYLET. THE LEAKING IS NOTICED AT THE INITIAL PLACEMENT AS WELL AS AFTER THE CATHETER HAS BEEN REMOVED. THEY REMOVED THE SHEATH PRIOR TO TRANSPORTING THE PT TO THE ICU. NO PT INJURY REPORTED. NO PROLONGED OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26479 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59398000

    Patients

    Seq Age Sex Outcome Treatment
    1