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

Model Number BG3510-5-J

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

Patient Problem Unspecified Infection (1930)

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, "according to the hospital, infection was confirmed at the anastomotic site between the artificial blood vessel and the aorta.We have attempted to conduct further hearings, but no additional information was obtained.Doctor's comment: it is unknown whether the infection is attributed to the use of bioglue.".

Manufacturer Narrative

A lot number nor a surgery date was provided therefore a manufacturing review could not be performed.No information was provided as to when/what symptoms were exhibited, testing conducted to confirm the infection, treatment for the infection, or when/if the infection had resolved.It is also unknown how much bioglue was used during the original procedure, if other products or materials were used, or if infection was already present.Per the ifu (instructions for use) warning, bioglue is not to be used in the presence of infection.The ifu lists infection as a potential and observed adverse event that may occur with the use of bioglue.There is insufficient information available to definitively determine the root cause of the reported event.Bioglue undergoes a validated terminal sterilization process; it is unlikely the infection is related to the product.All risks identified have been mitigated as far as possible and residual risk is acceptable.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, "according to the hospital, infection was confirmed at the anastomotic site between the artificial blood vessel and the aorta.We have attempted to conduct further hearings, but no additional information was obtained.Doctor's comment: it is unknown whether the infection is attributed to the use of bioglue.".

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8615284
• MDR Text Key: 145223996
• Report Number: 1063481-2019-00030
• 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: 07/26/2019

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: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other