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

Model Number BG UNK

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Spinal Column Injury (2081); No Information (3190)

Event Type  Injury  

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 the (b)(6) distributor reported that a neurosurgeon was not happy with bioglue after a procedure.Additional information received relayed that 5 ml of bioglue was used in a spine stabilization procedure.The bioglue was applied to an infected field, and used as an adjunct to sutures.No other materials were used for reinforcement with bioglue applied over.The bioglue did not polymerize, and it was allowed the full 2 minutes for polymerization to occur.This surgeon is a frequent user of bioglue.The bioglue was removed from the patient, but it was not sent to pathology for any testing.All preparation steps were followed from the ifu.The syringe was primed and de-aired.A standard tip was used for the application of the bioglue.No other preparation steps were performed outside of those within the ifu.Subsequent information received relayed that the tissue was already infected when bioglue was applied.A re-operation was performed and it was found the bioglue had not polymerized.The surgeon was working on the vertebrae.The patient is doing well.No additional information will be forthcoming.

Event Description

According to the initial report the slovakia distributor reported that a neurosurgeon was not happy with bioglue after a procedure.Additional information received relayed that 5 ml of bioglue was used in a spine stabilization procedure.The bioglue was applied to an infected field, and used as an adjunct to sutures.No other materials were used for reinforcement with bioglue applied over.The bioglue did not polymerize, and it was allowed the full 2 minutes for polymerization to occur.This surgeon is a frequent user of bioglue.The bioglue was removed from the patient, but it was not sent to pathology for any testing.All preparation steps were followed from the ifu.The syringe was primed and de-aired.A standard tip was used for the application of the bioglue.No other preparation steps were performed outside of those within the ifu.Subsequent information received relayed that the tissue was already infected when bioglue was applied.A re-operation was performed and it was found the bioglue had not polymerized.The surgeon was working on the vertebrae.The patient is doing well.No additional information will be forthcoming.

Manufacturer Narrative

Based on the information available at the time of this report, there is not enough evidence to definitively determine the cause of the observed event.Per the product¿s instruction¿s for use (ifu), the following warning is stated: ¿do not use bioglue in the presence of infection and use with caution in contaminated areas of the body¿.There is insufficient information available to definitively determine the root cause of the reported events.It is stated in the report that bioglue was applied to an infected field.There are adequate precautions and warnings in the ifu stating to not use bioglue in the presence of infection.No further action required.The reported event could not be confirmed.No sample received and the lot number is unknown.No new risks were identified during the course of the risk management departmental complaint investigation.There are adequate precautions and warnings in the ifu stating not to use bioglue in the presence of an infection.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.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• MDR Report Key: 9882480
• MDR Text Key: 190619570
• Report Number: 1063481-2020-00002
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/04/2020
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization