MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES

Model Number BG3515-5-US

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2015

Event Type  malfunction  

Event Description

According to the report, "during open heart surgery, the surgeon did de-airing, dry the target site, priming the syringe and applying the bioglue to the target site.But, the surgeon felt bioglue did not polymerise well like before and just flowed down.So, he opened another 2 ea.Of bioglue, and applied to the target sites again, but he felt same situation.Finally, he used 3 ea.Of bioglue 5ml for 1 patient, and completed this operation.".

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11734248
• MDR Text Key: 250669125
• Report Number: 1063481-2016-70031
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2016
• Device Model Number: BG3515-5-US
• Device Catalogue Number: BG3515-5-US
• Device Lot Number: 15MUV027
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention