BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER SET

    MDR report key: 1822522 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13980
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO EDWARDS FOR ANALYSIS. THE 9F INTRODUCER WAS RECEIVED WITH A SWAN-GANZ CATHETER AND CONTAMINATION SHIELD. EXAMINATION OF THE INTRODUCER VALVE CONFIRMED THE WIPER GASKET TO BE MISALIGNED. LEAK TESTING WAS PERFORMED, 250MMHG WATER CONFIRMED LEAKAGE WHEN THE CATHETER WAS REPOSITIONED IN OR OUT OF THE INTRODUCER. THERE WAS NO LEAKAGE OBSERVED WITH THE CATHETER REMOVED FROM THE VALVE. THE CATHETER WAS EXAMINED AND THERE WAS NO VISIBLE DAMAGE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THIS LOT OF PRODUCTS WHICH REVEALED THAT THE LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINUOUS CARDIAC OUTPUT CATHETER WAS INSERTED WITH THE INTRODUCER. IT WAS STATED THAT BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTASIS VALVE AND BLOOD WAS RETAINED INSIDE THE CONTAMINATION SHIELD. LEAKAGE STOPPED WHEN THE CATHETER WAS REMOVED AND THE INTRODUCER WAS REMOVED AFTER THE OPERATION. THERE WAS LEAKAGE OF INFUSION SOLUTION AND TRANSFUSION BLOOD WHEN THE CLINICIAN INJECTED FROM THE SIDE PORT. IT WAS INDICATED THAT THERE WAS NO RESPONSE TO FLUID ADMINISTRATION AND BLOOD TRANSFUSION, AND THE HEMODYNAMIC VALUES WERE DETERIORATING. IT SEEMED QUITE ABNORMAL; THE CLINICIAN CHECKED UNDER THE DRAPE AND FOUND ALL THE TRANSFUSION HAD LEAKED OUT FROM THE INTRODUCER. OPEN-HEART SURGERY WAS PERFORMED ON THIS PATIENT, AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER SET INTRODUCER SET DQY EDWARDS LIFESCIENCES, PR M700F9J 58863652

    Patients

    Seq Age Sex Outcome Treatment
    1