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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE
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CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE Back to Search Results
Model Number BG3510-5-J
Device Problems Malposition of Device (2616); Material Deformation (2976)
Patient Problem Pseudoaneurysm (2605)
Event Date 07/25/2014
Event Type  Injury  
Event Description
Bioglue was used for an aortic dissection in an ascending aorta replacement surgery.The date of procedure is unknown.Bioglue was applied to the proximal false lumen; it is unknown if bioglue was used on the suture line.It is unknown how much bioglue was used, if other materials were used, and if the target field was dry at the time of application.A false aneurysm was recognized around the coronary ostium and a re-procedure was performed.During the re-procedure, it was found that a "black substance" adhered to the outside of the graft near the suture line.
 
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Manufacturer Narrative
Bioglue was used for an aortic dissection in an ascending aorta replacement surgery.The date of procedure is unknown.Bioglue was applied to the proximal false lumen; it is unknown if bioglue was used on the suture line.It is unknown how much bioglue was used, if other materials were used, and if the target field was dry at the time of application.A false aneurysm was recognized around the coronary ostium and a re-procedure was performed.During the re-procedure, it was found that a "black substance" adhered to the outside of the graft near the suture line.The "black substance" was returned to cryolife and the sample had a texture similar to that of hardened bioglue.However, it was not clear whether the sample, either partially or entirely, was bioglue.The gross examination could not provide adequate results.The sample was submitted for pathological examination for further evaluation; the final diagnosis from the pathology examination was the sample was an "acellular amorphous material consistent with bioglue." possible lot numbers were determined and it was confirmed that all records were controlled, available for review, and met all specifications.A review was performed of the available information.Based on the information available at the time of the report, a cause of the false aneurysm observed in this patient could not definitively be determined.Bioglue was applied to the proximal false lumen; however, it is unknown if bioglue was used on the suture line, how much bioglue was used, if other materials were used, if the target field was dry at the time of application, or how long postoperatively the false aneurysm was observed.A black substance, which was determined to be consistent with bioglue, was found adhered to the outside of the graft near the suture line.It is unknown whether the "black substance" was found on the proximal or distal suture line.Due to the lack of specific details regarding the application of bioglue and the exact location of the bioglue found upon reoperation, it is unclear how the bioglue may have become adhered to the graft near the suture line; however, it is possible that bioglue dripped or ran to this area, or was inadvertently applied to this area.
 
Event Description
Bioglue was used for an aortic dissection in an ascending aorta replacement surgery.The date of procedure is unknown.Bioglue was applied to the proximal false lumen; it is unknown if bioglue was used on the suture line.It is unknown how much bioglue was used, if other materials were used, and if the target field was dry at the time of application.A false aneurysm was recognized around the coronary ostium and a re-procedure was performed.During the re-procedure, it was found that a "black substance" adhered to the outside of the graft near the suture line.
 
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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 Key4052173
MDR Text Key4735736
Report Number1063481-2014-00037
Device Sequence Number1
Product Code MUQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberBG3510-5-J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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