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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML JAPAN; GLUE, SURGICAL, ARTERIES
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CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML JAPAN; GLUE, SURGICAL, ARTERIES Back to Search Results
Model Number BG3510-5-J
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
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 initial report, on (b)(6) 2020 the patient was undergoing an aortic arch replacement due to aortic dissection.The bioglue was applied to the false lumen proximal end and the suture line.An appropriate amount of bioglue was applied.Felt was used as reinforcement.The area was dry where bioglue was applied.The vessel/graft was clamped and depressurized prior to the application of bioglue.It is unknown what the condition/integrity of the native tissue where the bioglue was applied.The bioglue was applied into the false lumen at the proximal end and suture line.The bioglue could not be worked well.Adhesion failure occurred.The surgeon then applied the bioglue outside of the surgical field to confirm if the bioglue worked.It was confirmed that the bioglue worked well.The surgeon stated "since it was confirmed that there is no functional problem out of the surgical field, the bioglue might have been worked [working] properly." additional information received relayed that the surgeon has experience using bioglue for approximately 2~10 times.The bioglue syringe was primed and de-aired before use.
 
Manufacturer Narrative
Based on the information available, there is not enough evidence to definitively determine the cause of the observed event.We are unable to definitively determine the cause of the events observed.However, the statement that bioglue performed correctly outside the surgical field, suggests that the event may have been caused by improper application technique.Further details are not available.No further action required.The reported event could not be confirmed.No sample was received for evaluation.No new risks were identified during the course of the risk management complaint investigation.The bioglue risk file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu (instructions for use).This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
Event Description
According to the initial report, on (b)(6) 2020 the patient was undergoing an aortic arch replacement due to aortic dissection.The bioglue was applied to the false lumen proximal end and the suture line.An appropriate amount of bioglue was applied.Felt was used as reinforcement.The area was dry where bioglue was applied.The vessel/graft was clamped and depressurized prior to the application of bioglue.It is unknown what the condition/integrity of the native tissue where the bioglue was applied.The bioglue was applied into the false lumen at the proximal end and suture line.The bioglue could not be worked well.Adhesion failure occurred.The surgeon then applied the bioglue outside of the surgical field to confirm if the bioglue worked.It was confirmed that the bioglue worked well.The surgeon stated "since it was confirmed that there is no functional problem out of the surgical field, the bioglue might have been worked [working] properly." additional information received relayed that the surgeon has experience using bioglue for approximately 2~10 times.The bioglue syringe was primed and de-aired before use.
 
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Brand Name
BIOGLUE SYRINGE 5-PACK, 10 ML JAPAN
Type of Device
GLUE, SURGICAL, ARTERIES
Manufacturer (Section D)
CRYOLIFE, INC.
1655 roberts blvd.
kennesaw GA 30144
MDR Report Key9699134
MDR Text Key202526444
Report Number1063481-2020-00083
Device Sequence Number1
Product Code MUQ
Combination Product (y/n)N
PMA/PMN Number
P010003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/28/2021
Device Model NumberBG3510-5-J
Device Lot Number19EJX012
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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