This is one of two products involved with the reported event.(b)(4).Upon deployment, two optease filters were stuck in their respective sheath introducers.Another optease filter was used and the procedure was completed successfully.There was no patient injury.Both filters were used in the same patient.The intended lesion is the vena cava.It is not clear if the sheath kinked.Per the voice of the customer, "the patient was thick." the products were inspected prior to use and appeared to be normal.The products were prepped properly according to the instruction for use (ifu).There were no difficulties reported in flushing the catheters prior to use.Both the optease filter and the sheath introducer will be returned for analysis.Two non-sterile cannula sheath from femoral 55cm kit products were received inside a plastic bag.Per visual analysis, the received cannula sheath presented a bent condition at 41 cm from distal end.The cannula sheath was received punctured at 36.5 cm from the distal end.The filter was received in the cannula sheath.One filter barb was observed protruding the cannula sheath wall at 36.5 cm from distal end.No other anomalies were observed.A functional test was performed on the received unit; with an obturator lab sample, the filter was push approximately 5 cm backwards then pushed forward.The filter was successfully advanced through and withdrawn from the cannula sheath.A sample syringe filled with water was attached to the cannula at the stopcock port and then flushed.Leakage was noted on the protruding cannula sheath area.The received cannula sheath od and id was measured near the bent condition and protruding area, the results were found within specification.Per microscopic analysis, the filter was taken out from cannula sheath and vision system inspected; filter, filter barb, and retrieval hook inspected and no anomalies were observed.The complaint reported by the customer as ¿filter- impeded - perforated sheath¿ for both devices was confirmed by analysis.The complaint reported by the customer as ¿cannula (csi/filters)- obstructed - in patient¿ for both devices was confirmed, due to filter protruding condition on cannula sheath as was received.In both devices received, a filter barb was noted to be protruding the cannula sheath.The exact cause of the perforated sheath condition found on cannula sheath as well as the bent condition could not be determined during the analysis.Procedural factors, handling process may contribute to the failure as reported.When the filter is passing an acute bend inside the sheath due to vessel tortuosity or if force is applied, the barbs have the potential to perforate the sheath.The ifu instructs ¿to slowly advance the filter into the sheath introduce by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.If the filter advancement is problematic, advance the sheath introducer to negotiate the curve, and then continue to advance the filter¿.Neither product analysis nor phr review results suggest that these damages found could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
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