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

Model Number	BG3502-5-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to the initial report, a post operative infection occurred.According to the complainant, patient is still being followed as of (b)(6) 2019.On (b)(6) 2018: cultured for staphylococcus aureus.On (b)(6) 2019: light growth of enterococcus faecalis and light growth of streptococcal a.Additional information was received."the infection that occurred at our facility was on a patient who had a lumbar laminectomy on (b)(6) 2018.We brought her back to the or [operating room] on (b)(6) when it was discovered that she had a csf [cerebrospinal fluid leak] leak from her initial surgery that required repair.The [product] was used for the second surgery, when the surgeon placed a blood patch to repair the csf leak.".
Event or Problem Description
According to the initial report, a post operative infection occurred.According to the complainant, patient is still being followed as of (b)(6) 2019.(b)(6) 2018: cultured for staphylococcus aureus.On (b)(6) 2019: light growth of enterococcus faecalis and light growth of streptococcal a.Additional information was received."the infection that occurred at our facility was on a patient who had a lumbar laminectomy on (b)(6) 2018.We brought her back to the or [operating room] on (b)(6) 2018 when it was discovered that she had a csf [cerebrospinal fluid leak] leak from her initial surgery that required repair.The [product] was used for the second surgery, when the surgeon placed a blood patch to repair the csf leak.".
Additional Manufacturer Narrative
A review of manufacturing records was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.The final product met all specification for release.The use of bioglue as defined in the case report for the repair of a csf leak is not an approved indication in the united states.The ifu (instructions for use) states under the contraindications: ¿bioglue for use in neurosurgery, including use as a dural sealant, is not an approved indication.Fda has not evaluated the safety and effectiveness in support of a neurosurgical indication; however, serious adverse events such as stroke, infection, meningitis, and cerebrospinal fluid leaks have been reported.¿.The use of bioglue in this case report is considered off-label use.Using bioglue for the repair of a csf leak is not an approved indication.The ifu states that bioglue should not be used in neurosurgery, and serious adverse events such as infection have been reported, bioglue undergoes terminal sterilization using a validated sterilization process and is therefore unlikely to have caused the reported infection.This event does not identify additional hazards or modify the probability and severity of existing hazards.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
• Common Device Name: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8461873
• Report Number: 1063481-2019-00014
• Device Sequence Number: 16888500
• Product Code: MUQ
• UDI-Device Identifier: 10877234000239
• UDI-Public: 10877234000239
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2019
• Device Model Number: BG3502-5-US
• Device Catalogue Number: BG3502-5-US
• Device Lot Number: 17MUW004
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/05/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other