The device was not returned for evaluation.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire; however, the reported kink appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.
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