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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information and without the device to analyze, a cause of the speculated cable break could not be determined.The reported popping noise appears to be a result of the cable break.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional mitraclip device referenced is filed under a separate medwatch report number.
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