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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

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 initial reports, about 8 months ago a patient was reopened (reason for reoperation unknown) and a seroma was found around the bioglue.

Manufacturer Narrative

A review of the available information was performed.Bioglue was used approximately 8 months ago.When the patient was re-opened the surgeon noted thrombus, later clarified to be a seroma around the bioglue.The following information is unknown: original surgery, indication for re-opening the patient, where bioglue amount of bioglue used, and where bioglue was applied.Also, no additional information was given about the seroma.Pictures were provided, however a description of the pictures and its relation to the reported event was not provided.The possibility that the material could be bioglue cannot be ruled out.Seromas have not been reported with the use of bioglue in cardiac procedures in literature.Due to the limited information provided no root cause or conclusion could be made.There is no indication following research to date that a seroma following cardiac procedures have been caused by bioglue.No further action required.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 initial reports, about 8 months ago a patient was reopened (reason for reoperation unknown) and a seroma was found around the bioglue.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8566375
• MDR Text Key: 143609286
• Report Number: 1063481-2019-00024
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other