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

Model Number BG UNK

Device Problems Off-Label Use (1494); Chemical Problem (2893)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

According to the bioglue post market survey form received via email on 01-mar-2021, a surgeon performed a reintervention due to a csf leak after using bioglue during the reconstruction of sellar [cellar] floor by trans-sphenoidal approach.Additional information provided by the director ra & bme of the (b)(4) bioglue distributor."this incident report by the surgeon is the reply on your survey for noncardiac case through website last week.For this survey, we have asked the surgeon and filled with his reply.And this is not recently occurred, and he has experienced over 10 years ago when he worked at sinchon severance hospital.This is just reply on your survey and not serious any more now, and also he has any information on this issue any more, too." no additional information forthcoming.

Event Description

According to the bioglue post market survey form received via email on 01-mar-2021, a surgeon performed a reintervention due to a csf leak after using bioglue during the reconstruction of sellar [cellar] floor by trans-sphenoidal approach.Additional information provided by the director ra & bme of the south korean bioglue distributor."this incident report by the surgeon is the reply on your survey for noncardiac case through website last week.For this survey, we have asked the surgeon and filled with his reply.And this is not recently occurred, and he has experienced over 10 years ago when he worked at sinchon severance hospital.This is just reply on your survey and not serious any more now, and also he has any information on this issue any more, too." no additional information forthcoming.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11462782
• MDR Text Key: 239395088
• Report Number: 1063481-2021-00012
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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
• Date Manufacturer Received: 03/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention