Investigation - evaluation.A review of the complaint history, device history record, documentation, instructions for use and quality control data was conducted during the investigation.The product will not be returned for the investigation.If the device becomes available complaint will be reopened and investigation will be performed at that time.Review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Review of device history record found three non-conformances but none of these non-conformances were related to the complaint failure mode.The ifu included with the device states,"this catheter will not transmit thermal energy along its light fibers to patient tissue.Any excessive thermal damage from the light source will manifest at the catheter/light plug junction, and will not be transmitted along the catheter length.And "start illumination with the light source at the lowest setting, as many light sources product thermal energy at varying temperatures.This will limit the possibility of thermal damage at the catheter/light plug junction.It is inadvisable to use any light source at its highest setting, unless the light source`s actual thermal energy output is unknown." based on the provided information, a root cause of the event was related to product handling or user handling related.Based on the failure investigation, the product has been obsolete and withdrawn from the field.
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