Manufacturing review: the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample a failure to advance to the treatment site could not be confirmed.The device was found without damage/conspicuity, and a device compatible 0.035" guidewire could be inserted and fully advanced without difficult.An indication for a manufacturing related issue could not be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported failure could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addressed the potential risk.The ifu states: 'flush the inner lumen of the stent system with heparinized normal saline prior to use.', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage, the ifu states: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' the ifu demands for 6f introducer sheath, and a 0.035" guidewire.After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.
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