Product analysis a visual inspection found that the proximal end of the guidewire lumen is detached 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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It was reported that an attempt was made to use a turbohawk plus to treat a plaque lesion in the mid distal superficial femoral arte ry/popliteal artery.Degree of tortuosity was little.Degree of calcification was moderate.Device was inspected with no issues noted.Device was prepped per ifu.It was reported that mid to distal isr (in-stent restenosis) was treated with the hawk over 0.014 non -medtronic wire.Once physician was finished hawking he started removing the device and noticed resistance.Once he inspected the sheath he noticed wire prolapse, the device would not pull into the sheath.After tugging a few times he was able to remove the device and the wire all together.After inspection, it was confirmed that the device was fully removed and angiography confirmed that nothing was left behind in the patient.Pta (percutaneous transluminal angioplasty) followed post hawk and physician was able to complete his procedure.No patient injury reported.When the device was returned for evaluation, it was noted that the device was damaged.
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