BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD

    MDR report key: 1052007 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07285
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCER BROKE COMPLETELY AT THE SUTURE POINT AND SEPARATED WITH THE SWAN=GANZ CATHETER CONNECTING BOTH BROKEN LUMENS. EVENT OCCURRED AT THE END OF AORTIC VALVE REPLACEMENT SURGERY. MEDICAL INTERVENTION THAT REQUIRED WAS THE REMOVAL OF THE CATHETER AND REINSERTED A NEW CATHETER OVER GUIDE WIRE. IT WAS STATED BY THE DOCTOR THAT THE SWAN-GANZ CATHETER WAS OBSTRUCTING THE LUMEN FROM A LARGE AMOUNT OF BLOOD COMING OUT OF THE LUMEN. PATIENT IS DOING FINE. FOLLOWED UP WITH DR. AND HE FURTHER STATED THAT THE BROKEN INTRODUCER WAS DRIPPING ON THE SHOULDER- IV FLUIDS, WHICH WAS SUTURED TO THE SKIN. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD PERCUTANEOUS SHEATH INTRODUCER KIT DYB EDWARDS LIFESCIENCES, PR I505BF9HC 58478232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other