BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2853419 · Received November 30, 2012

    Report

    Report Number
    3008500478-2012-00334
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS STATED THAT THERE WAS NO MALFUCTION OF THE DEVICE. A HEMATOMA WAS CAUSED DURING THE PROLONGED PLACEMENT PROCESS. THE PRODUCT WAS NO 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 CAPAS DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE MD EXPERIENCED DIFFICULTY IN PLACEMENT OF THE PROPLEGE CORONARY SINUS CATHETER. THE PLACEMENT WAS ATTEMPTED FOR OVER AND HOUR AND A LARGE HEMATOMA WAS NOTED ON THE PATIENT'S RIGHT NECK. A 5,000 UNITS OF HEPARIN WERE GIVEN PRIOR TO LINES BEING PLACED. THE DECISION WAS MADE TO ABORT THE CASE AS IT WOULD NOT BE POSSIBLE TO FULLY HEPARINIZE THE PATIENT WITH SUCH A LARGE HEMATOMA. THE LOT NUMBER IS UNKNOWN, THE PRODUCT WAS DISCARDED BY THE HOSPITAL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other