BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN BG3510-5-J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-10-15 for BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN BG3510-5-J manufactured by Cryolife, Inc. - Kennesaw.

Event Text Entries

[123742971] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10

[123742972] According to the initial report received, following replacement of the ascending aorta in which bioglue was applied to distal suture line, proximal end of suture line, false lumen proximal, and distal end,? A few months later perigraft seroma/fluid retention was observed around proximal suture line of vascular graft , where bioglue was previously applied. Reportedly, it is not atheroma, but sterile fluid collection. Redness was also observed around upper sternum and drainage is being done?.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1063481-2018-00039
• MDR Report Key: 7965569
• Report Source: FOREIGN,USER FACILITY
• Date Received: 2018-10-15
• Date of Report: 2018-11-26
• Date Facility Aware: 2018-09-19
• Date Mfgr Received: 2018-09-19
• Date Added to Maude: 2018-10-15
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ROCHELLE MANEY
• Manufacturer Street: 1655 ROBERTS BLVD.
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal: 30144
• Manufacturer Phone: 7704193355
• Manufacturer G1: CRYOLIFE, INC.
• Manufacturer Street: 1655 ROBERTS BLVD. NW
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal Code: 30144
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Generic Name: GLUE,SURGICAL,ARTERIES
• Product Code: MUQ
• Date Received: 2018-10-15
• Model Number: BG3510-5-J
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRYOLIFE, INC. - KENNESAW
• Manufacturer Address: 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2018-10-15