Model Number SGC0701 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 09/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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The customer reported the device is not returning.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 being filed to report the thrombus.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.After the steerable guide catheter (sgc) reached the right atrium, a clot was observed.The physician decided to cancel the procedure.The physician did not believe it was caused by the sgc but a chemo port.There was no treatment performed but heparin was not reversed.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Based on available information, the cause of the reported thrombosis was due to procedural conditions.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use is 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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