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 Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

According to the initial report received, "the patients underwent endoscopic pituitary surgery where bioglue was used as an adjunct to sellar/skull base repair.¿in 50 patients, 1 (2%) suffered a post-operative csf leak.There were no instances of post-operative meningitis.In total, 1/50 (2%) patient was treated with oral antibiotics by their general practitioner for presumed sinusitis 2 weeks post-operatively.None of the patients has required rhinological intervention/surgery during the follow-up period (median 24 months, range 11¿41).¿.

Event Description

Additional information was received from the author: i don't have the lot number.It may possibly be in the patient's medical records.However, the following points may be useful for you: the purpose of this paper & its message is that despite previously published concerns we found that bioglue did not cause an inflammatory reaction & did not increase infection rate, when used in transnasal / transsphenoidal operations.We reported the postoperative csf leak rate in this group of patient but it wasn't the main subject of this paper.We are preparing further papers on that.Bioglue does not result in csf leak.Csf leak is a well known postoperative complication of transnasal surgery for pituitary tumours & skull base tumours.The rate of postoperative csf leak depends on several factors but most importantly the pathology of the tumour being removed, the extent of bony and dural defect being repaired, the method of repair & the experience of the surgeon.For example extended approaches particularly for certain types of tumour such as meningioma & craniopharyngioma have a high incidence of postop csf leak.".

• 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 maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14547956
• MDR Text Key: 292975942
• Report Number: 1063481-2022-00008
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2022

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 Operator: Lay User/Patient
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 07/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other