It was reported, a (b)(6) male was undergoing an unspecified procedure via the left anterior tibial artery.After the third removal from the patient's anatomy, a cxi support catheter was found to have torn at the distal tip,1mm past the radiopaque marker.The highly calcified target lesion was located in the superficial femoral artery.Left pedal approach was used to gain access to the lesion.Other devices in use were another manufacturer's 4fr sheath, and an unspecified 0.35 wire guide.A power injector was not used.No resistance was felt during insertion or removal of the complaint device and the fitting was not wiped down with any solutions.During this same procedure, a cook balloon catheter was inflated inside an old stent and ruptured.Please reference medwatch 1820334-2019-01259 for details of this event.The procedure was successfully completed without patient adverse effect.No further procedures were needed.The complaint device has not been release from the complaint facility.It is not known if it will be returned to aid in the manufacturer's investigation of this event.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿ instructions, quality control, and specifications 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.However, while reviewing the subassembly lot of this device, a potentially related nonconformance was noted.While this nonconformance may be related to the reported failure, it should be noted that the affect unit was scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states "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 this event could not be traced to the device but to the patient¿s condition.Reportedly, the target area was highly calcified.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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