BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 2140059 · Received June 25, 2011

    Report

    Report Number
    2954761-2011-00040
    Event Type
    Injury
    Date Received
    June 25, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF PRODUCT VOLUMES AND RISKS OF TAMPONADE WERE DISCUSSED WITH THE OPERATING SURGEON. THEREFORE, NO FURTHER INVESTIGATION IS REQUIRED. PRODUCT APPLICATION REVIEW HAS BEEN COMPLETED. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: BASED ON THE ADDITIONAL INFORMATION RECEIVED WE CAN STATE THE FOLLOWING: AN INFLAMMATORY REACTION HAS NOT BEEN IDENTIFIED. EXCESS COSEAL (IT APPEARS THAT AN 8 ML KIT HAS BEEN USED IN THE MEDIASTINUM OF A (B)(6)) HAS BEEN IDENTIFIED. A LOCAL INFECTION CAUSED BY COSEAL HAS BEEN EXCLUDED (NEGATIVE CULTURE OF THE REMOVED MATERIAL). THE CRITICAL CLINICAL CONDITION OF THE CHILD HAS NOT BEEN CAUSED BY A PRODUCT-INDUCED INFECTION. AN UNIDENTIFIED INFECTION (WBC AND CRP INCREASED) MAY HAVE BEEN THE MAJOR CONTRIBUTING FACTOR. NEVERTHELESS, INDEPENDENTLY FROM A POTENTIAL INFECTION, A CERTAIN LEVEL OF TAMPONADE OF THE HEART DUE TO EXCESS COSEAL IMPACTING THE CLINICAL STATUS OF THE PATIENT CANNOT BE RULED OUT. WE RECOMMEND CONFIRMATION OF THE VOLUME OF PRODUCT APPLIED, AND IN CASE 8 ML OF COSEAL HAVE BEEN APPLIED, (TAKING INTO ACCOUNT THE SWELLING CHARACTERISTICS OF THE PRODUCT) THE SURGEON REQUIRES RETRAINING WITH SPECIAL EMPHASIS ON THE NEED OF APPLYING ONLY A THIN LAYER AND TAKING INTO ACCOUNT THE 4 TIMES VOLUME SWELL OF COSEAL. (B)(4). AFTER FOLLOW-UP WITH THE OPERATING SURGEON A FOLLOW-UP SUBMISSION WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: IN ORDER TO ASSESS THE POTENTIAL CONTRIBUTION OF COSEAL TO THIS PATIENT'S POST OPERATIVE REACTION THE FOLLOWING INFORMATION IS REQUIRED: PREOP DIAGNOSIS, RELEVANT HISTORY AND PLANNED SURGICAL PROCEDURE. PRODUCT APPLICATION DETAILS INCLUDING METHOD OF APPLICATION AND DOSAGE. DETAILS OF DIAGNOSIS OF INFLAMMATION TO THE PATIENT'S TISSUE - DID THE PATIENT HAVE AN IMMEDIATE REACTION TO THE COSEAL AND IF SO WAS THE PRODUCT REMOVED INTRAOPERATIVELY. TREATMENT REQUIRED FOR THE INFLAMMATORY REACTION. CURRENT STATUS OF THE PATIENT. (B)(4). AS THIS CASE IS NOT ASSESSABLE, THIS CASE IS BEING CONSERVATIVELY REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE BAXTER SALES REPRESENTATIVE CALLED TO ADVISE HE RECEIVED PARTIAL INFORMATION ABOUT AN ADVERSE EVENT FROM DR. (B)(6). THE INFORMATION AVAILABLE IS AS FOLLOWS: ONE OF THE SIZES (UNKNOWN) OF COSEAL WAS USED AT FOUR DIFFERENT TIMES DURING A PEDIATRIC CASE (DATE AND TIME UNKNOWN) AND IS SUSPECTED TO HAVE CAUSED INFLAMMATION TO THE PATIENT'S TISSUE. DR. (B)(6) MAY BE CONTACTED TO OBTAIN ADDITIONAL INFORMATION. PATIENT PRESENT: YES, HOW SURGERY WAS COMPLETED: UNKNOWN, SURGERY SUCCESSFUL: NO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM DR. (B)(6): DR (B)(6) EXPLAINED THAT HE HAS BEEN USING COSEAL FOR ADHESION PREVENTION IN HIS PEDIATRIC CARDIAC SURGERIES SINCE 2001. HIS METHOD OF APPLICATION IS WITH THE SPRAY DEVICE. FROM ALL OF THE INFORMATION HE VOLUNTEERED, HE STATED THAT IN ALL OF THE YEARS HE HAS USED COSEAL FOR ADHESION PREVENTION, HE HAS NEVER SEEN A REACTION AS THIS. IN FACT, WHEN HE DOES THE STAGING PROCEDURES, AND THE NEXT SURGERY A FEW MONTHS LATER, HE STATED THERE IS NOT EVER ANY EVIDENCE OF COSEAL INSITU. SURGERY PERFORMED ON (B)(6) 2011 - COMPLETION FONTAN PROCEDURE. DR. (B)(6) STATED THAT HE SPRAYED COSEAL - HE BELIEVES IT WAS AN 8 ML KIT- ON THE ANTERIOR MEDIASTINUM . NO OTHER PRODUCT WAS USED ON THIS CHILD. DR (B)(6) ALSO STATED THAT HE HAD USED COSEAL IN THIS PATIENT'S PREVIOUS THREE CARDIAC STAGING PROCEDURES. ON (B)(6) 2011, CP WAS RE-OPERATED ON BY DR. (B)(6), AS A FEW DAYS PRIOR TO THIS DATE, CP HAD AN ELEVATED WBC, AND AN ELEVATED C REACTIVE PROTEIN. DR. (B)(6) SUSPECTED AN INFECTION. PRIOR TO THE SURGERY, PATIENT CP, HAD A CT SCAN, AND ON THE SCAN IT APPEARED AS THOUGH THERE WAS A COLLECTION OF SOME SORT OF MATERIAL AROUND THE HEART. POSSIBLY A HEMATOMA, OR INFECTION. UPON ENTERING THE CHEST, DR. (B)(6) NOTED THERE WAS A THICK GELATINOUS COVERING, APPROXIMATELY 1 CM THICK IN SOME AREAS, AROUND THE HEART. DR. (B)(6) PEELED OFF THE MATERIAL. DR. (B)(6) MENTIONED THAT THE MATERIAL APPEARED TO RESTRICT CERTAIN PORTIONS OF THE HEART WHERE IT WAS MOST ADHERENT. ALL MATERIAL WAS REMOVED. WHEN ASKED HOW THE CHILD WAS RECOVERING, DR. (B)(6) STATED THAT CP WAS STRUGGLING. I WANTED TO MAKE SURE THAT WE HAD THE CORRECT INFORMATION ON THE VOLUME OF COSEAL THAT WAS USED, AS WELL AS THE LOT NUMBER. DR. (B)(6) INFORMED ME THAT HE WOULD CHECK WITH THE OPERATING ROOM FOR US. ADDITIONAL FOLLOW-UP: LOT: HA101131, PRODUCT CODE: 934072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSEAL SURGICAL SEALANT SEALANT,POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD 934072 HA101131

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other