As reported, during an unknown procedure to treat a severely calcified chronic total occlusion in the superficial femoral artery, the tip of a cxi support catheter frayed.The patient, of unknown age and gender, reportedly had tortuous anatomy.Access was obtained in the femoral artery and the complaint device was advanced over another manufacturer's 0.018 inch guide wire; however, the device did not pass through the lesion.Upon removal of the device, the tip was noted to be frayed.Another device of the same type was used to complete the procedure.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
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Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which state, ¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction." based on the information provided and no product returned, investigation has concluded that the device failure is most likely due to the patient¿s anatomy, particularly the reported severe calcification and total occlusion of the target lesion.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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