The device was returned for analysis.The reported difficulty to insert and tip break were not confirmed or tested based on condition of the returned device.The additional damage to the inner member and outer sheath is likely due to case circumstances.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 other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported difficulty.It may be possible that the reported loose tip (nose cone) was inadvertently handled during preparation and affected the integrity of the inner member and as such the guide wire was not able to properly be loaded during insertion causing difficulty; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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