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

Model Number BG UNK

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

Patient Problems Inflammation (1932); Speech Disorder (4415)

Event Type  Injury  

Event Description

A publication, by mistry et al titled: previous bioglue repair mimicking cardiac infection with 18f-fdg pet imaging reported the following case."the ventricular septal rupture (vsr) and pseudo-aneurysm repair were performed using bioglue - a surgical adhesive used to achieve hemostasis in large vessel.¿ ¿we present a patient with incidental 18f-fdg uptake in the site of previous cardiac repair with bioglue, mimicking an infectious process.¿ additional imaging using ¿wbc studies have higher specificity to detect active infectious disease"·5 and, in this case, was able to rule-out infection, confirming the presence of an inflammatory process, even 5 years after surgery.".

Event Description

A publication, by mistry et al titled: previous bioglue repair mimicking cardiac infection with 18f-fdg pet imaging reported the following case."the ventricular septal rupture (vsr) and pseudo-aneurysm repair were performed using bioglue - a surgical adhesive used to achieve hemostasis in large vessel.¿ ¿we present a patient with incidental 18f-fdg uptake in the site of previous cardiac repair with bioglue, mimicking an infectious process.¿ additional imaging using ¿wbc studies have higher specificity to detect active infectious disease"·5 and, in this case, was able to rule-out infection, confirming the presence of an inflammatory process, even 5 years after surgery.".

Event Description

A publication, by mistry et al titled: previous bioglue repair mimicking cardiac infection with 18f-fdg pet imaging reported the following case."the ventricular septal rupture (vsr) and pseudo-aneurysm repair were performed using bioglue - a surgical adhesive used to achieve hemostasis in large vessel.¿ ¿we present a patient with incidental 18f-fdg uptake in the site of previous cardiac repair with bioglue, mimicking an infectious process.¿ additional imaging using ¿wbc studies have higher specificity to detect active infectious disease"·5 and, in this case, was able to rule-out infection, confirming the presence of an inflammatory process, even 5 years after surgery.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12981760
• MDR Text Key: 285641488
• Report Number: 1063481-2021-00039
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

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 Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/12/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male