MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES

Model Number BG3510-5-J

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

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report "two cases in which sterile fluid retention was observed around the suture line where bioglue was previously applied.".

Manufacturer Narrative

There is no evidence in the case report which indicates that bioglue caused the sterile fluid retention.Seromas have not been reported with the use of bioglue in cardiac procedures.There is insufficient evidence to determine if the seroma is related to bioglue, the vascular graft, or the anastomotic line.There is no indication following research to date that a seroma following cardiac procedures, especially aortic have been caused by bioglue.No further action recommended.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the initial report "two cases in which sterile fluid retention was observed around the suture line where bioglue was previously applied." additional information received via email "two cases in which sterile fluid retention was observed around the suture line where bioglue was applied during replacement of the ascending aorta due to acute type a aortic dissection.The appropriate amount of bioglue was used, the area was dry, and no mention of any anomalies of the native tissue.No intervention or additional treatment required.The patients are kept under follow-up.No allergies to bovine materials noted.The patients' conditions are improved.It is unknown if bioglue was previously used in the patients.The surgeon is a frequent user of bioglue.The instructions for use were followed.The bioglue was allowed to polymerize for a full two minutes.No bioglue was peeled from any surface.It is unknown if the true lumen and cardiovascular structures were protected.It is unknown if appropriate precautions were taken to avoid negative pressure within the graft or vessel.The bioglue syringe was primed and de-aired.The mixing tip was fully seated.".

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8574182
• MDR Text Key: 143849838
• Report Number: 1063481-2019-00026
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Hospitalization