BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 615995 · Received June 16, 2005

    Report

    Report Number
    2954761-2005-00006
    Event Type
    Injury
    Date Received
    June 16, 2005
    Date of Event
    March 31, 2005
    Report Date
    June 15, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NBE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CASE REFERS TO A PT WHO WAS OPERATED SOME WEEKS AGO FOR A COMPLEX CASE OF TETRALOGY OF FALLOT WITH SUSPENDED PULMONARY ARTERY. TWO MI OF COSEAL WERE APPLIED, NOT SPRAYED, AT THE END OF THE PROCEDURE TO PREVENT CARDIAC ADHESION FORMATION. WITH THE MANUAL SPRAY, THIS FORMED A QUITE THICK PASTE. 20 TO 30 MINUTES LATER, WHEN THE CHILD WAS AGAIN IN THE OPERATING ROOM, THE O2 SATURATION DECREASED IN A DRAMATIC MANNER AND FORCED THE SURGEON TO REOPEN THE CHEST. HE OBSERVED A QUITE IMPORTANT SWELLING OF THE MATERIAL, WHICH HAS BEEN REMOVED WITHOUT ANY DIFFICULTY. THE CHEST WAS FURTHER CLOSED WITHOUT ANY PARTICULARITY IN THE FOLLOW UP. THE EVENT ON OCCURRED IN 2005, WITH COSEAL LOT# 041007 (LOT NUMBER REQUIRED TO DETERMINE IF BAXTER MANUFCTURED PRODUCT). WHEN REOPENING THE CHEST, THE SURGEON FOUND A COSEAL CUBE COMPRESSING THE PULMONARY INFUNDIBULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSEAL SURGICAL SEALANT POLYMERIZING SEALANT NBE BAXTER HEALTHCARE CORPORATION NA 041007

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY Life Threatening| R