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

Catalog Number 934074

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter postal code: 3500.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient underwent an aortic valve replacement procedure wherein coseal surgical sealant was applied.As the surgeon was suturing the aorta and drying the surface, coseal was applied onto the sutures.After one minute the clamp was released.The coseal worked per product specifications ¿at the beginning¿.The patient was ¿well polymerized and it looked dry¿.Approximately 15 seconds later, the coseal ¿came loose and surface started to bleed again¿.The surgeon had to put ¿sutures again to restore the bleeding¿.No further information was available at the time of this report.

Manufacturer Narrative

Based on additional information received, coseal was determined not to be a factor in the reported adverse event.

Manufacturer Narrative

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: 18839359
• MDR Text Key: 336921259
• Report Number: 1416980-2024-00923
• Device Sequence Number: 1
• Product Code: NBE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 934074
• Device Lot Number: HA221228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• 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
• Treatment: UNSPECIFIED SUTURES
• Patient Outcome(s): Required Intervention