(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the tip detachment likely occurred due to inadvertent mishandling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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