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Catalog Number SGC0702 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
Air Embolism (1697)
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Event Date 10/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.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 the steerable guide catheter leak.It was reported the mitraclip procedure was performed to treat grade 3 degenerative mitral regurgitation (mr).When the steerable guide catheter (sgc) was inserted into the left atrium, air bubbles were observed in the aorta.The air bubbles were successfully aspirated.Shortly after air bubbles were also discovered in the left atrial appendage which were also aspirated.Again, shortly after, air bubbles appeared in the left atrium, requiring aspiration.The decision was made to remove and replace the sgc.An air leak and broken valve is suspected; however, no visible damage was observed.No more air entered the patient with the new sgc.The procedure was finished successfully.One clip was implanted, reducing mr to 1.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.All available information was investigated, and the reported leak/splash and broken hemostasis valve were not confirmed via returned device analysis.The discrepancy between what was reported (leak) and what was observed (no leaks) may have been due to the user technique versus the returned product analysis.Additionally, the discrepancy between what was reported suspected broken (damaged) valve, and what was observed (no damage to the valve) was due to the user¿s perception for the cause of the leak and was not confirmed at the account a review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The reported patient effect of air embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.All available information was investigated and a cause for the reported leak in this complaint could not be determined.The reported broken hemostasis valve was the user¿s perception for the cause of the leak.Air embolism was associated with the procedural circumstances of the leak at the account.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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