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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

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 intitial reports, a jr.Surgeon from (b)(6) said there was abscess formation in few of the patients post bioglue usage.

Manufacturer Narrative

A review of manufacturing records could not be performed as a definitive lot number was not provided by the complainant.Additionally, direct observation of the product could not be performed as no product was returned.A review of the available information was performed.A jr.Surgeon from the department of neurosurgery, (b)(6) general hospital (b)(6) said there was abscess formation in a few of the patients post bioglue usage and was the reason they stopped using it.The following information is unknown: the amount of bioglue used in each patient nor details regarding how bioglue was used; any additional products and/or materials used (i.E., sutures, dural patch material, etc.); how soon postoperatively the events occurred; the exact number of patients affected or exact number of surgeons involved; or additional information such as any culture results, imaging, preexisting conditions of patients, ages of patients, etc.Given the information provided, the cause of the abscess formations cannot be definitively determined.Based on the information available at the time of this report, an exact root cause of the events observed in the patients cannot be conclusively determined.Bioglue undergoes a validated terminal sterilization process, it is unlikely the abscesses are infections related to the product.Foreign body inflammatory reactions, which are known to occur with bioglue, cannot be excluded.Additional information is required to more fully evaluate the complaint.Should additional information become available, it will be reviewed, and the investigation will be reopened.No further action is required at this time.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. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9257121
• MDR Text Key: 164877164
• Report Number: 1063481-2019-00068
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/09/2019
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 12/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other