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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient underwent a video-assisted thoracic surgery for right upper lobe wedge with lung nodule.Coseal was used to prevent an air leak.It was reported primary sealing was achieved with staples.It was further reported an air leak test was performed prior to closure, and no leak was confirmed.The post-operative period was uncomplicated with healthy normal lung function.One day post-operative, an air leak was discovered (one staple line was the only source).The patient was discharged home with a chest tube and heimlich valve due to the air leak.No additional information is available.

Manufacturer Narrative

Additional information received which sustains the coseal performed as intended and the air leak was due to the disease state of the patient and the friable tissue.Coseal is intended to reduce the incidence of post-operative air leak.Based on additional information received, coseal was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COSEAL
• Type of Device: 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: 17683350
• MDR Text Key: 322638870
• Report Number: 1416980-2023-04464
• Device Sequence Number: 1
• Product Code: NBE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention