Patient weight is unavailable.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The suspect lld device was returned and evaluated on 11 september 2019 with a philips cross-functional team.During the evaluation it was confirmed there were two breaking points on the lld device, but they were slightly different from what the philips representative had reported.The most proximal breaking point, break point one, was located on the core mandrel just distal of the crimped hypotube of the proximal loop.The proximal end of the device, including the proximal loop and the crimped hypotube had not been returned for evaluation.The team measured from the proximal side of the wave form, to break point one or where the crimped hypotube would be located.The distance measured to be 20.75 inches.The specification for this length measurement is 22.25 +/ 0.5 inches.Since the 20.75 inches does not fall within that specification, it was determined the device broke on the core mandrel before the crimped hypotube.This means the crimped hypotube could not have been a factor for break point one.Upon evaluating break point one under the microscope, it was determined there was a slight indentation at the end of the break point.This indentation could be representative of a kink or damage before the lld device broke.The most distal break point, break point two, was located on the core mandrel 2 inches distal of the wave form and proximal to the braided mesh.The distal end of the device, including the majority of the working length and braided mesh, was not returned for evaluation.Looking at break point two under a microscope, it was determined the break point was at an angle.The angle of the break point could indicate a kink or damage to the device before the device broke.Both break points had some indication for kinking or damage.A kink or damage can lead to a weakened stress point on the device, which in turn could cause the kinked or damaged location to be more susceptible to failing when traction forces are applied to the device.The team was unable to determine the cause of the possible kink or damage to the device.
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