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

Model Number BG3510-5-J

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

According to initial reports, "patients developed infection after surgery for aortic dissection during last year.The relationship between infection and bioglue was unknown.

Manufacturer Narrative

The manufacturing records for the multiple lot numbers provided were reviewed.As a definitive lot number is unknown, there¿s no way to know what part, if any, bioglue would have to the reported event and any noted non-conformance.Attempts at additional information were unsuccessful.A review of the available information was performed.Per the report, "5-6 patients developed infection after surgery for aortic dissection during last year.The doctor stated that the relation between infection and bioglue was unknown, but no infection was developed after changing to fibrin glue in surgeries afterwards.¿ no information was provided as to when symptoms were exhibited, testing conducted to confirm the infections, treatment for the infections, or when/if the infections had resolved.It is also unknown how much bioglue was used during the original procedures, if other products or materials were used, or if infection was already present.There is insufficient information available to definitively determine the root cause of the reported events.Bioglue undergoes a validated terminal sterilization process, it is unlikely the infection is related to the product.No further action required.The bioglue risk management file was reviewed.Assessment of potential root cause of the reported event cannot be performed due to the very limited information provided by the complainant.The fmeas indicate failure modes that could cause infection.The ifu provides instructions on the safe use of the device.Inflammatory reactions to bioglue are known to occur and adequate precautions and warnings are present in the ifu.No action is needed at this time.The reported event will continue to be monitored for trends.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 SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8837020
• MDR Text Key: 152511155
• Report Number: 1063481-2019-00041
• 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: 10/18/2019

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
• Distributor Facility Aware Date: 07/25/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other