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

Model Number BG3502-5-US

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

During tsa neuro surgery , the surgeon used bioglue (2ml) with 10cm applicator tip, as usual.But today, he felt bioglue was not polymerized well.After surgery, this bioglue has been discarded.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

During tsa neuro surgery , the surgeon used bioglue (2ml) with 10cm applicator tip, as usual.But today, he felt bioglue was not polymerized well.After surgery, this bioglue has been discarded.

Manufacturer Narrative

During tsa neuro surgery , the surgeon used bioglue (2ml) with 10cm applicator tip, as usual.But today, he felt bioglue was not polymerized well.After surgery, this bioglue has been discarded.Manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was conducted on the available information and no root cause was determined.

Event Description

During tsa neuro surgery , the surgeon used bioglue (2ml) with 10cm applicator tip, as usual.But today, he felt bioglue was not polymerized well.After surgery, this bioglue has been discarded.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL ADHESIVE
• 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: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4012952
• MDR Text Key: 20270998
• Report Number: 1063481-2014-00035
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BG3502-5-US
• Device Lot Number: 13MUW008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other