MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10ML; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Fever (1858)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Incidence of postoperative pyrexia of about 38 degrees has been observed after 2-3 weeks from the time of operation.It was considered to be infection-attributable in the beginning, but white blood cell count is stable and inflammation was within the normal range, the doctor now considers it might be bioglue-related.Bioglue was applied to false lumen, suture lines at aortic root as well as distal aortic arch.

Event Description

Incidence of postoperative pyrexia of about 38 degrees has been observed after 2-3 weeks from the time of operation.It was considered to be infection-attributable in the beginning, but white blood cell count is stable and inflammation was within the normal range, the doctor now considers it might be bioglue-related.Bioglue was applied to false lumen, suture lines at aortic root as well as distal aortic arch.

Manufacturer Narrative

Additional information received from the complainant does not attribute postoperative pyrexia to bioglue.Bioglue is a terminally sterilized product and it is highly unlikely it would contribute or be the cause of postoperative pyrexia.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.Additional information from the complainant indicates that the use of bioglue is not related to the reported event.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10ML
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8640662
• MDR Text Key: 146075160
• Report Number: 1063481-2019-00031
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: 18EJX001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/15/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other