Physician was attempting to use a turbohawk plus directional atherectomy along with non-medtronic 6fr sheath and spider fx guidewire during procedure to treat to treat a severely calcified lesion in the mid superficial femoral artery (sfa) with unknown percentage stenosis.The vessel was little tortuous.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that the wire prolapsed and the tip ended up becoming detached inside the destination sheath 6f.At that time the tip of the turbohawk plus was pulled back into the sheath and got stuck.The tip of the turbohawk plus then became detached while inside the 6f ansel sheath.The physician removed everything at this point (sheath, hawk, sider) in its entirety.Physician then gained access again and completed imaging to ensure no issues.There was no vessel damage.After gaining access again with a new sheath, angioplasty was done to the sfa and procedure was completed as normal with a closure device.There was no patient in jury reported.
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Product analysis: the turbohawk device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a plastic bag two biohazard bags.A visual inspection showed that the tip detached distal to the anchor pockets.There is plastic material, possibly pet stuck on the cutter, (photo 6) and there is biologics in the detached tip.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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