MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 2ML, US; GLUE,SURGICAL,ARTERIES

Model Number BG3502-5-US

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

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.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, "our thoracic surgeon has been using bioglue for closure/sealing bronchus for several cases.After operations were complete, the surgeon was very satisfied with performance of bioglue.But during icu and ward, some patients who used bioglue had fever symptoms.The surgeon could not be sure the cause of this fever symptoms is related with bioglue.".

Manufacturer Narrative

No additional information could be obtained.A review of the device history record could not be performed as the lot number(s) nor were dates of surgeries provided.The following is unknown: how much bioglue was used, if bioglue is used as an adjunct to sutures, or if the patients have any allergies or sensitivities to materials of bovine origin.Fever is a non-specific response to inflammation commonly seen after surgical procedures.Possible causes of post-operative fever are numerous and virtually impossible to attribute to any specific source.A fever as a result of a foreign body inflammatory response related to the use of bioglue cannot be excluded.Allergic reaction, inflammatory and immune response are listed as potential complications in the ifu (instructions for use).Based on the available information provided in the case report, we are unable to definitively determine the cause of the events observed.Given the non-specific nature of fever, it is not possible to determine what role, if any, bioglue could have played in the development of the fevers reported in this case.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.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 2ML, US
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9198769
• MDR Text Key: 166808091
• Report Number: 1063481-2019-00064
• 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
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

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: Health Professional
• Device Model Number: BG3502-5-US
• Device Catalogue Number: BG3502-5-US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/01/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other