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Model Number BG3510-5-J |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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