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

Model Number BG3515-5-US

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

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

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.".

Manufacturer Narrative

Corrected data: removed lot number 15muv027.A separate report will be filed for that lot number.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." the following additional information was requested: please confirm which lot number of bioglue was used during each attempt, what lot number of bioglue was successfully used, if there was any patient impact, such as prolonged surgery, what was the target site of the bioglue application, and operative notes in english.The distributor replied on (b)(6) 2015 that "[the surgeon] could not remember which lot no.Was used firstly and another attempt during the operation, but there was same situation that did not polymerize well and it took longer time that before for polymerizing for all three bioglue.After this operation, there was not any other event to the patient.[the application site was] ascending aorta and arch.They could not provide operative notes to us." the manufacturing records for lot number 15muv024 were reviewed and it was confirmed that all records were controlled, available for review, and met all release specifications per the device master record.The ifu provides the following instructions: "the residual air space must be removed prior to the bioglue application.Again, it is important to hold the assembled syringe upright to ensure that the air bubbles in the solutions are located at the top of the syringe.Purging of the air space can now be accomplished using two different methods: compress the plunger only until the solutions are event with the top of the syringe body.Once the residual air space has been removed the syringe is ready for priming and immediate use.Compress the plunger until both solutions can be visibly seen in the base of tip.The airspace has now been removed, but this tip is now occluded with polymerized bioglue and will need to be changed prior to priming and application to the target site." the ifu also states "each applicator tip must be primed prior to bioglue application.Priming ensures the bioglue solutions are properly mixed.The surgeon should compress the plunger and expel a narrow ribbon of bioglue approximately 3cm long onto a sterile disposable surface," and "bioglue works best when the target surgical field is dry.A dry surgical field can be described as a field that does not restain with blood within 4-5 seconds after wiping dry with a surgical sponge." the root cause of the reported event is unknown.The lot of bioglue passed functional qc release testing prior to shipment.Additionally, the ifu adequately illustrates proper site preparation prior to bioglue application.There is no indication that an error or deficiency occurred during manufacturing of the product by cryolife and the ifu adequately communicates risk.

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: 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5354307
• MDR Text Key: 35451033
• Report Number: 1063481-2016-00003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/03/2016
• Device Model Number: BG3515-5-US
• Device Lot Number: 15MUV024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• 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