MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. COSEAL SPRAY SET; SEALANT,POLYMERIZING

Catalog Number	0600021
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
Additional Manufacturer Narrative
A2: date of birth: the date of the birth is an unknown day in (b)(6).A4: weight: patient¿s weight is 3.980kg.Patient¿s height is 56.2cm.G1: device manufacturer postal code: 7860.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Five days prior to the receipt of this report, the patient underwent a thoracotomy (pulmonary artery banding) procedure wherein coseal spray set 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
Additional information was added to h6.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 SPRAY SET
• Common Device Name: SEALANT,POLYMERIZING
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LESSINES; boulevard rene branquart 80; lessines ; BE
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19657699
• Report Number: 1416980-2024-03350
• Device Sequence Number: 6540567
• Product Code: NBE
• UDI-Device Identifier: 00085412087788
• UDI-Public: (01)00085412087788(17)270111(10)32023492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PMA P030039
• 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 Catalogue Number: 0600021
• Device Lot Number: 32023492
• 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: 07/08/2024
• 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 REGULATOR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 4 KG