BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2930628 · Received January 28, 2013

    Report

    Report Number
    3008500478-2013-00374
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A MIS MVR THERE WAS BACKBLEEDING THROUGH THE INTRODUCER SHEATH OF THE PROPLEGE CORONARY SINUS CATHETER. "THE DEVICE WORKED WELL THROUGHOUT THE CASE. AT THE END OF THE CASE, THE DEVICE WAS REMOVED FROM THE SHEATH, AND THERE WAS BACKBLEEDING FROM THE SHEATH. THIS CONTINUED EVEN AFTER THE "SLICK" WAS PLACED INTO THE END OF THE SHEATH. THE SHEATH WAS REMOVED PRIOR AT THAT TIME. THIS SURGEON ROUTINELY SENDS PATIENTS TO ICU WITH THE SHEATH IN PLACE AS THEY GIVE MEDICATIONS, ETC., THROUGH THE 11 FR. SHEATH."THE SURGEON STATED THIS HAS HAPPENED 4-5 TIMES RECENTLY ALTHOUGH EDWARDS SALES TEAM WAS NEVER CONTACTED ABOUT THOSE INCIDENCES." NO FURTHER INFORMATION ABOUT THE ADDITIONAL CASES IS KNOWN. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37094 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1