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

Catalog Number	934071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Five days prior to the receipt of this report, the patient underwent a thoracotomy (pulmonary artery banding) procedure wherein coseal surgical sealant was applied.Three days later the patient developed a two-stage pulse arrhythmia upon awakening.Analgesia was added and the patient was monitored.Circulation was stable.Two days later sedation was terminated and the two stage pluse did not reoccur.The following day the patient was transferred to a general medical unit.An echocardiogram was performed, and a small amount of pericardial fluid was found around the entire circumference of the heart.Diastolic dimension is less than 1mm.Two days after that, a follow up echocardiogram was performed, and a pericardial effusion was observed around the entire heart.The diastolic dimension was about 7 mm, which had rapidly increased compared to the day before yesterday.Emergency drainage was performed.A median subcutaneous incision of about 4 cm was made to reach the pericardial sac at the diaphragmatic plane, resulting in a clear red pale bloody pericardial effusion.The pericardial effusion drained approximately 35 ml.Since there was no persistent bleeding in the pericardial sac, a 15fr drain was placed in the pericardial sac and the wound was opened and closed.The patient was hospitalized for an unspecified amount of time and has since recovered from the events.No further information was available at the time of this report.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: no information regarding explantation or an expected explantation date has been received.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
H11: 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.

• Brand Name: COSEAL
• 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: 19657698
• Report Number: 1416980-2024-03351
• Device Sequence Number: 15088186
• Product Code: NBE
• UDI-Device Identifier: 05413765404627
• UDI-Public: (01)05413765404627(17)241213(10)HA240101
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; SPRAY SET REGULATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 4 KG