MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COSEAL SURGICAL SEALANT; SEALANT,POLYMERIZING

Catalog Number	934071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a pulmonary artery banding wherein coseal surgical sealant was applied utilizing easyspray and coseal spray set.The patient was admitted to the pediatric intensive care unit.Four days postoperative (postop) an echocardiogram was performed, and no abnormalities were noted.Both the intrapericardial and mediastinal drains were removed.The patient was transferred to a general medical pediatric unit in ¿stable condition.¿ the following day, at 0100 serum exudate was observed originating from the wound.Two hours later, an echocardiography showed a small amount of pericardial fluid all around the wound.There was a ¿possibility of leaking fluid from the suture gap in the wound;¿ however, the wound edge was not broken open and was temporarily protected with a dressing and film.¿ predonine was started as ¿pericardial fluid therapy.¿ seven hours later, an echocardiography showed increased pericardial effusion around the entire circumference (diastolic 1.5-2.0 mm, systolic 3.5 mm [up to 6 mm in some areas]).Six and half hours later the echocardiography was reevaluated, and the deterioration was assessed.The patient was diagnosed with cardiac tamponade due to pericardial effusion.An emergency drainage was decided as the next course of action.The surgery began three hours and 18 minutes later.Pericardial fluid was aspirated, and the pericardial section was flushed.No new bleeding was noted.A 10fr drain was placed in the pericardium.Surgery was completed and the patient was deemed recovered.No further information was available at the time of this report.
Additional Manufacturer Narrative
A2: date of birth: the patient¿s date of birth was reported as an unknown date in (b)(6) 2024.A4: weight: 2741g.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COSEAL SURGICAL SEALANT
• Common Device Name: SEALANT,POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19071312
• Report Number: 1416980-2024-01599
• Device Sequence Number: 17307900
• Product Code: NBE
• UDI-Device Identifier: 05413765404627
• UDI-Public: (01)05413765404627(10)HA240101(17)241213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Catalogue Number: 934071
• Device Lot Number: HA240101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 05/16/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/30/2024; 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COSEAL SPRAY SET; EASYSPRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Female