(b)(4).Internal file number - (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 was unable to determine a cause for the reported tip detachment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported the procedure was performed to treat a lesion with no calcification in the proximal common femoral artery.The supera stent was deployed at the target lesion successfully.Prior to removal of the delivery system, when the thumbslide was retracted, the nosecone separated.Two guide wires and a balloon catheter were advanced to capture the separated nosecone and retrieve it successfully.No additional information was provided.
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