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 Embolism (1829); Urinary Tract Infection (2120)

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 received for journal article: ¿do renal tumor characteristics affect the number of hemostatic agents used during partial nephrectomy?¿ retrospective study of 71 patients who undergone partial nephrectomy (pn) surgery due to renal mass between january 2013 and february 2019. Each patient was administered one or more hemostatic agent (ha) during the procedure. Article mentions postoperative complications of urinary leakage, arteriovenous fistula, embolization, urinary tract infection. However they do not state whether these complications occurred to those 17 patients that bioglue was applied to.

• 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; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 9375187
• MDR Text Key: 168581011
• Report Number: 1063481-2019-00072
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/26/2019 Patient Sequence Number: 1