Product analysis a 0.014¿ guidewire from the lab was loaded into the distal end of the tip and exited the proximal end of the tip.A visual inspection confirmed that the guidewire lumen on the housing is ripped medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Physician was attempting to use a turbohawk atk atherectomy device during a procedure to treat a 200mm calcified lesion in the patient¿s left proximal mid distal superficial femoral artery (sfa).No vessel tortuosity and moderate vessel calcification were reported.Lesion exhibited 50% stenosis.Artery diameter reported as 5mm.There were no abnormalities reported in relation to anatomy.The device was inspected with no issues noted.The device was prepped per the ifu with no issues identified.It was reported the guidewire cavity fell off.Physician followed standard procedures to open the rotational catheter to use.During the intraoperative cleaning plaque of the collection chamber, it was found that the guidewire cavity fell off.A balloon was replaced for dilation, and the operation went smoothly without affecting patient safety.No patient injury reported.Guidewire lumen tore/ripped.Damaged component remained attached, however when the device was returned the lumen was fully detached from the device.
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