This is being filed to report an unspecified tissue injury.This will be filed.When the steerable guide catheter (sgc) was inserted into the left atrium, something similar to tissue was confirmed by echo on the tip.Upon removal of the sgc from the body, there was no deposit on the tip, and it was not possible to distinguish between thrombus and septal tissue.Additional aspiration was required, which is medical intervention to prevent a serious injury.There was no clinically significant delay.
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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 this event.Based on the available information, the cause of the reported thrombus or tissue injury cannot be determined.The reported thrombus or tissue injury as listed in the instructions for use (ifu) are known possible complications associated with mitraclip procedures.The reported medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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