MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE, SURGICAL, ARTERIES

Model Number BG UNK

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.

Event Description

According to the initial report, "it was revealed that back in 2017 a neurosurgery department had patients that experienced an increase in temperature to 40 0 celsius (1040 f) after the application of bioglue.This was only observed in the patients that had bioglue used.".

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, "it was revealed that back in 2017 a neurosurgery department had patients that experienced an increase in temperature to 40 0 celsius (1040 f) after the application of bioglue.This was only observed in the patients that had bioglue used." additional information was received.Patients were discharged from the hospital.There is no information available on either postop complication or reoperation.Bioglue lot number records are not available.Boxes were discarded.Bioglue was used for dura sealing after brain surgery.Up to 2ml of bioglue was used.The fever developed the next day after surgery and stayed 2-3 days for 5 out of the 8 patients.Some patient underwent antibiotic treatment.

Manufacturer Narrative

According to the initial report, "it was revealed that back in 2017 a neurosurgery department had patients that experienced an increase in temperature to 40 0 celsius (1040 f) after the application of bioglue.This was only observed in the patients that had bioglue used." additional information - patients were discharged from the hospital.There is no information available on either postop complication or reoperation.Bioglue lot number records are not available.Boxes were discarded.Bioglue was used for dura sealing after brain surgery.Up to 2ml of bioglue was used.The fever developed the next day after surgery and stayed 2-3 days for 5 out of the 8 patients.Some patient underwent antibiotic treatment.It is unclear what type of surgeries were performed, if other products were used, or what technique was used for the dura sealing.It is unknown if the patients have any allergies or sensitivities to materials of bovine origin.Fever is a non-specific response to inflammation.There are many potential causes of inflammation following surgery, including tissue injury, infection, medications, and implants such as bioglue.A fever could be a result of foreign body inflammatory response related to the use of bioglue.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.Based on the available information regarding the eight patients, we are unable to definitively determine the cause of the events observed.This event does not identify additional hazards or modify the probability and severity of existing hazards per the risk management file.The instructions for use indicate allergic reaction, inflammatory and immune response as potential complications.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, "it was revealed that back in 2017 a neurosurgery department had patients that experienced an increase in temperature to 40 0 celsius (1040 f) after the application of bioglue.This was only observed in the patients that had bioglue used." additional information* patients were discharged from the hospital.There is no information available on either postop complication or reoperation.Bioglue lot number records are not available.Boxes were discarded.Bioglue was used for dura sealing after brain surgery.Up to 2ml of bioglue was used.The fever developed the next day after surgery and stayed 2-3 days for 5 out of the 8 patients.Some patient underwent antibiotic treatment.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8132622
• MDR Text Key: 129309600
• Report Number: 1063481-2018-00050
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/06/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other