Catalog Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Bradycardia (1751)
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Event Date 11/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The customer reported the device was 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 the leak and treatment with aspiration and medication.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the left atrium.The dilator was removed for aspiration and air was observed in the syringe.It was confirmed that the sgc was not against any structures of the heart.Aspiration was performed and the air was removed.The clip delivery system (cds) was advanced to the mitral valve.While grasping, the patients heart rate suddenly dropped to 13 beats per minute (bpm).Atropine was administered and the patient was stabilized.The clip was deployed without issue, reducing mr to 1-2.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported in leak in this incident could not be determined.The definitive cause for bradycardia could not be confirmed.The reported patient effect of bradycardia is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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