BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 1040204 · Received May 8, 2008

    Report

    Report Number
    2954761-2008-00025
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER MEDICAL DIRECTOR ASSESSMENT: COSEAL IS INDICATED FOR USE IN SEALING SUTURE LINES ALONG ARTERIAL AND VENOUS RECONSTRUCTIONS AND IN PATIENT'S UNDERGOING CARDIAC SURGERY TO PREVENT OR REDUCE THE INCIDENCE, SEVERITY AND EXTENT OF POST SURGICAL ADHESION FORMATION. THE USE OF COSEAL TO ENFORCE CLOSURES OF GASTROINTESTINAL FISTULA IS NOT INDICATED. AS A RESULT, THE DESCRIBED INCIDENT IS THE RESULT OF AN ERROR IN USE. THE EARLY BREAK DOWN OF THE PRODUCT IN AN ENVIRONMENT WITH A LOW PH, AND A HIGH ENZYMATIC ACTIVITY MAY ALSO HAVE CONTRIBUTED TO THE EVENT. IT IS ALSO A WELL KNOWN GUIDANCE IN SURGERY THAT SYNTHETIC MATERIALS SHOULD BE USED WITH EXTREME CAUTION IN CLEAN-CONTAMINATED SURGICAL FIELDS. IT IS RECOMMENDED TO RE-TRAIN THE REPORTING SURGEON ON THE FOLLOWING: SURGEON SHOULD BE ASKED TO STOP THE USE OF COSEAL IN THIS TYPE OF SURGERY. COSEAL IS NOT INDICATED FOR SEALING OF THE RECONSTRUCTION OF FISTULAS, SINCE THIS APPROACH REQUIRES A FIBRIN-BASED, AND NOT A SYNTHETIC SEALANT. HEALING OF FISTULAS IS A LENGTHY PROCESS THAT EXCEEDS THE LENGTH OF DEGRADATION FO COSEAL. THE USE OF A FIBRIN SEALANT THAT SUPPORTS THE HEALING PROCESS WOULD BE THE RECOMMENDED ALTERNATIVE IN SUCH CHALLENGING. RAYMOND F. NISTOR, MD BIOSURGERY. REMEDIAL ACTION: RETAINING OF THE SURGEON IN ANOTHER COUNTRY IS CURRENTLY BEING SCHEDULED.

    Description of Event or Problem · 1

    MALE POSTINTUBATION SUBGLOTTIC STENOSIS GRADE IV / IV, DR. PREVIOUSLY PERFORMED SURGERY DUE TO DISTRACTION OF JAW WITH TRACHEOSTOMY. THE PARTIAL CRICOTRACHEOTOMY RESECTION WITH CLOSURE OF TRACHEOSTOMY WAS PERFORMED IN 2008, ADMINISTERING COSEAL ON THE CRICOTRACHEOTOMY'S SUTURE THROUGH DIRECT APPLICATION OF 2 ML, BEING IT A CLEAN CONTAMINATED WOUND, UNDER ANTIBIOTIC COVER WITH AMOXICILLIN/CLAVULANIC. ON THE 4TH DAY, POST-OP PRESENTS SUPPURATION THROUGH SURGICAL WOUND AND EXIT OF "SILICONE-LOOKING LIKE MATERIAL" THROUGH THE WOUND THAT IS NO MORE THAN THE FRAGMENTED COSEAL. WE SHALL NOW PROCEED TO THE CLEANING OF THE SURGICAL WOUND AND LOCAL TREATMENT WITH A GOOD OUTCOME. SUBSEQUENTLY, THE PATIENT SUFFERED RESIDUAL ANTERO-STENOSIS SUBGLOTTIC GRADE II/IV WHICH REQUIRES NEW SURGERY THROUGH ANTERO-LARYNXTRACHEOPLASTY (IN 2008), APPLYING IN THIS CASE TISSUCOL RAPID 2 ML DIRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention