Received one dis150 in original package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.The guidewire was bent.The probable cause for this is advancing the wire while encountering resistance.A two-year lot history review shows a total of two devices for this lot number and failure mode.A device history record review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 22 reports, regarding 27 devices, for this device family and failure mode.During this same time frame 104,717 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0003.Per the instructions for use, the user is advised the following: remove the guidewire from packaging and remove the tape attached to wire.Carefully inspect it for any damage that may have occurred during transit or handling.Additionally, the ifu states that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.We will continue to monitor for trends through the complaint system to assure patient safety.
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