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

Model Number BG3502-5-G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

According to an email on 12/20/2018: "in neurosurgery, a patient had a surgery and 5 months after the scar started to leak.They said [the product] was still not resorbed but that there was no risk of inflammation as per the tests.They had to re-operate the patient to take out excess/fibres of [the product].".

Event Description

According to an email on 12/20/2018: "in neurosurgery.A patient had a surgery and 5 months after the scar started to leak.They said product was still not resorbed but that they were no risk of inflammation as per the tests.They had to re-operate the patient to take out excess/fibres of product." information located in initial report received via email on 12/20/2018 states: "63-year-old patient, managed in neurosurgery on (b)(6) 2017 for a meningioma of incidental discovery on (b)(6) 2017.Use of product for dural closure.The postoperative course is simple.Two months later, when a consultation, highlighting a purulent discharge from the upper part of the scar.Decision of completion of a new intervention on (b)(6) 2018 for deep sampling.During this intervention, removal of rather large fragments of glue non-resorbed organism at 5 months of the initial intervention.The bacteriological analysis of the samples is negative." an email was received on 01/21/2019 stating, "all i know about this is that they used the product as they would usually in neuro.The customer had a leak on the scar area 5 months after the surgery.They had to re-operate and remove the excess product.As far as we know, it is normal if product is not reabsorbed after 5 months.

Manufacturer Narrative

A review was held of the available information.The cause of the purulent discharge is unknown.The instructions for use (ifu) lists inflammatory and immune response as a potential complication.The product degrades via proteolysis.The resorption rate depends on the amount of product used and where it is applied.However, residual of the product remaining at 5 months is not unexpected.The international ifu states to trim away excess or irregular adhesive edges after polymerization.Also, the product should be applied in thin layers.Based on the information provided it is unclear if the surgeon relates the discharge around the scar to the excess product.A product review revealed no non-conformance's, deviations, or waivers are associated with the product.All incoming, in-process, and final inspections were completed.All inspections were within specification limits.There was not a high scrap rate at any point in the processing of the product.No change orders are noted during the production of the product.The patient noted purulent discharge in which a bacterial analysis came back negative and a large fragment of glue was reportedly removed.The product degrades via proteolysis.The resorption rate depends on the amount of product used and where it is applied.However, residual of the product remaining at 5 months is not unexpected.The international ifu (instructions for use) states to trim away excess or irregular adhesive edges after polymerization.Also, the product should be applied in thin layers.Based on the information provided it is unclear if the surgeon relates the discharge around the scar to the excess product noted.A definitive root cause is unknown.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8248181
• MDR Text Key: 133069505
• Report Number: 1063481-2019-00002
• 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
• Report Date: 02/21/2019

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-G
• Device Lot Number: 17MGW005
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/20/2018
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 02/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR