(b)(4).The device was not returned for analysis.The reported difficulties and subsequent treatment appear to be related to an interaction of the device with patient anatomy due to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The other perclose proglide device is filed under a separate medwatch manufacturer report reference number.
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