A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to insert could not be tested due to the device condition.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to insert; however, the reported stent dislodgement appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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