Catalog Number SGC0702 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Air Embolism (1697)
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Event Date 03/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This is filed to report air bubbles noted in the left atrium during the procedure.It was reported that the mitraclip procedure was to treat mixed mitral regurgitation (mr) with grade 3+.After, the steerable guide catheter (sgc) was advanced to the left atrium air bubbles were noted in the left atrium.Troubleshooting and aspiration was performed and there was no indication that the sgc was the cause of air embolism.The patient remained stable, but the procedure was ended to check the neurological status of the patient.A computed tomography (ct) was performed which was without diagnostic findings.There was no sgc issue.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a cause for the reported air embolism cannot be determined.However, air embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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