BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 3092536 · Received May 3, 2013

    Report

    Report Number
    2032282-2013-00046
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS REPORT ON A PATIENT ENTERED A CLINICAL TRIAL STUDY: RANDOMIZED CONTROL TRIAL TO INVESTIGATE THE EFFECTIVENESS OF COSEAL; SURGICAL SEALANT IN REDUCING INTRA-ABDOMINAL ADHESIONS FOLLOWING THE KASAI HEPATOPORTOENTEROSTOMY FOR BILIARY ATRESIA (CLINICALTRIALS.GOV IDENTIFIER: (B)(4)). APPROXIMATELY 2.5 MONTHS AFTER COSEAL WAS APPLIED DURING THE INITIAL SURGERY FOR BILIARY ATRESIA THE PATIENT REQUIRED REOPERATION TO LYSE ADHESIONS WHICH HAD FORMED BETWEEN THE LIVER SURFACE WHERE COSEAL HAD BEEN APPLIED AND THE PATIENT'S BOWEL LEADING TO BOWEL OBSTRUCTION. THE ONLY EXCLUSION CRITERIA IN THIS TRIAL ARE PATIENTS WITH BILIARY ATRESIA ALONG WITH MALROTATION. BILIARY ATRESIA IS A BLOCKAGE OF THE BILE DUCT CONNECTING THE LIVER TO THE GUT. THE SURGERY PERFORMED CONNECTS THE SMALL BOWEL DIRECTLY TO THE LIVER TO ALLOW FOR DRAINAGE OF BILE. MALROTATION IS A CONGENITAL ANOMALY OF ROTATION OF THE MIDGUT, WHERE THE SMALL BOWEL IS FOUND MAINLY ON THE RIGHT SIDE OF THE ABDOMEN WITH THE CECUM DISPLACED FROM THE RIGHT LOWER QUADRANT INTO THE EPIGASTRIUM. THESE ADDITIONAL CONGENITAL ANOMALIES WERE LISTED AS CAUSE TO EXCLUDE PATIENTS SUCH AS THIS FROM THE TRIAL. THE ADDITIONAL TISSUE MANIPULATION AND INJURY TO THE DUODENUM, WHERE NOT COVERED WITH COSEAL. COSEAL ON THE SURFACE OF THE LIVER FAILED TO PREVENT ADHESIONS STRONG ENOUGH TO CAUSE OBSTRUCTION OF BOWEL. REINFORCEMENT OF THE EXCLUSION CRITERIA AND RATIONALE FOR THAT EXCLUSION SHOULD BE REVIEWED WITH THE REPORTER. ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THE EXCLUSION CRITERIA FROM THE SITE. BAXTER'S FINAL ASSESSMENT: DESPITE TREATMENT OF THE LIVER SURFACE WITH COSEAL, FORMATIONS OF ADHESIONS OCCURRED AND SUBSEQUENTLY LEAD TO A BOWEL OCCLUSION (DUODENAL OBSTRUCTION). SINCE ADHESIONS OCCURRED IN THE AREA WHERE COSEAL HAS BEEN APPLIED, ONE CANNOT EXCLUDE THAT COSEAL CONTRIBUTED TO THE DESCRIBED COMPLICATION. BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. THE BATCH REVIEW WAS PERFORMED FOR LOT HA120959 AND FOUND NO ABNORMALITIES DURING THE MANUFACTURING PROCESS. PER HAYWARD, ALL IN-PROCESS AND RELEASE ACCEPTANCE CRITERIA WERE MET AND REVIEWED PRIOR TO THE RELEASE OF THE LOT. BAXTER (B)(4) DISCOVERED NO SIMILAR COMPLAINTS REPORTED FOR LOT HA120959, DSD LOT 120843S AND 120847S AND PEG LOT 120950S. NO TREND WAS IDENTIFIED. THE MANUFACTURING FACILITY CONCLUDED THAT NO FURTHER ACTION IS NEEDED AT THIS TIME. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LIMITED INFORMATION, THE CASE IS CURRENTLY NOT ASSESSABLE AND THE CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CLINICALTRIALS.GOV IDENTIFIER: (B)(4). CLINICAL TRIAL STUDY: RANDOMISED CONTROL TRIAL TO INVESTIGATE THE EFFECTIVENESS OF COSEAL SURGICAL SEALANT IN REDUCING INTRA-ABDOMINAL ADHESIONS FOLLOWING THE KASAI HEPATOPORTOENTEROSTOMY FOR BILIARY ATRESIA IT WAS REPORTED TO BAXTER (B)(4) THAT A PATIENT IN A (B)(6) CLINICAL TRIAL STUDY HAS BEEN DIAGNOSED WITH BOWEL OBSTRUCTION IN WHICH COSEAL WAS USED. SAMPLE IS NOT AVAILABLE FOR EVALUATION. UPDATE (B)(6) 2013: FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; PATIENT'S AGE IS (B)(6) AND GENDER FEMALE. PATIENT WAS DIAGNOSED WITH BOWEL OBSTRUCTION DUE TO BOWEL ADHESIONS. A SURGERY WAS PERFORMED TO RELEASE ADHESIONS AND THE PATIENT IS NOW WELL. --------- ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: WHAT SURGERY WAS BEING PERFORMED? KASAI PORTOENTEROSTOMY, LADD'S PROCEDURE, APPENDECTOMY, RESECTION OF MECKEL'S. WHAT WAS THE SURGICAL TECHNIQUE? OPEN LAPAROTOMY AND DISSECTION AROUND LIVER AND BOWEL. WAS THERE ANY FOLLOW-UP PROCEDURE PERFORMED? IF SO, WHAT WAS PERFORMED? NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193986 COSEAL SURGICAL SEALANT SEALANT, POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD HA120959

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other