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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
Excessive amount of bg was used; after applied to both provcimal (proximal) and distal suture lines, surgeon repeatedly applied bg to the same sites and tissue around the suture lines until one syringe was used up.Inflammatory reaction (creation of thick constructs, reportedly "tissue") has been reported at the sites where bioglue was previously applied.No intervention has been required yet, and this inflammatory reaction and creation of tissue were confirmed based on the ct scan.We have asked for the ct image, but the data is pending.Surgeon later admitted there was some inappropriate use of the device and commented this probably led to the reported incident.He also said the amount of tissue created seemed to be way more in amount to believe bioglue was simply denatured.
 
Manufacturer Narrative
A lot number nor a surgery date was provided therefore a manufacturing review could not be performed.The following is unknown: how much bioglue was used during the procedure, how much time passed before the inflammatory reaction was observed, and if any other materials/surgical glues were used.In the bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ inflammatory reaction is listed as an observed and potential adverse event in the ifu as well.Foreign body reactions have been reported with the use of bioglue.Hewitt et al.Performed an animal study where bioglue was applied to a sheep¿s aorta; histopathologically, bioglue generates only a minimal inflammatory response (hewitt et al 2001).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli 2003).The exact amount of bioglue used is unknown; however, the surgeon states ¿there was some inappropriate use of the device for this case¿.If a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.Root cause/conclusion: the root cause of the observed events is due to the excessive application of bioglue as stated by the surgeon.Secondary inflammation and fibrosis may have also been contributing factors.Inflammatory reactions to bioglue are known to occur and adequate precautions and warning are present in the ifu.The ifu provides instructions on the safe use of the device.Inflammatory reactions to bioglue are known to occur and adequate precautions and warnings are present in the ifu.All risks identified have been mitigated as far as possible by design and process and residual risk is acceptable.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
Excessive amount of bg was used; after applied to both provcimal (proximal) and distal suture lines, surgeon repeatedly applied bg to the same sites and tissue around the suture lines until one syringe was used up.Inflammatory reaction (creation of thick constructs, reportedly "tissue") has been reported at the sites where bioglue was previously applied.No intervention has been required yet, and this inflammatory reaction and creation of tissue were confirmed based on the ct scan.We have asked for the ct image, but the data is pending.Surgeon later admitted there was some inappropriate use of the device and commented this probably led to the reported incident.He also said the amount of tissue created seemed to be way more in amount to believe bioglue was simply denatured.
 
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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. nw
kennesaw GA 30144
MDR Report Key8747963
MDR Text Key149629642
Report Number1063481-2019-00036
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,foreign
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberBG3510-5-J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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