BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER SET

    MDR report key: 1822462 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13978
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 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 8F INTRODUCER WAS RECEIVED WITH TWO SWAN-GANZ CATHETERS. A CONTAMINATION SHIELD WAS NOT RETURNED. CUSTOMER REPORT WAS CONFIRMED FOR LEAKAGE. EXAMINATION OF THE INTRODUCER VALVE CONFIRMED THE WIPER GASKET TO BE MISALIGNED. LEAK TESTING AT 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. A LOT NUMBER WAS REPORTED, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BLOOD LEAKAGE WAS OBSERVED IN THE CONTAMINATION SHIELD." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER SET INTRODUCER SET DQY EDWARDS LIFESCIENCES, PR M095F8J 58857396

    Patients

    Seq Age Sex Outcome Treatment
    1