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Catalog Number H1-M |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis a visual inspection of the housing/tip found that the cutter protruding out through the proximal end of the housing.The proximal end of the housing where the anchor pockets are situated is damaged, 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 have not 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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Event Description
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A physician was using a hawkone atherectomy device for treatment of a plaque lesion in the mid right superficial femoral artery.There was moderate calcification and mild tortuosity.A 6fr non medtronic sheath and a 0.014" non medtronic guidewire was used.The vessel was pre dilated.The ifu was followed.It was reported the nosecone was bent when packing and could not pack all the way.The tip did not detach.It was possible to turn off the thumbswitch, the cutter driver/thumbswitch stop functioning when outside of the patient.The device was safely removed from the patient.No deformation noticed in the cutter and no pieces of the cutter missing.Another hawkone was opened, the ifu was followed again and it was reported that while outside the body during cleaning, they had trouble opening the blade and pushed real hard on the switch and the blade busted out the side of nosecone.The position of the cutter in relation to the nosecone during device removal from the patient was outside of the housing for the first device.A third hawk was opened to complete the case.No patient injury was reported.When the device was retuen for evaluation, it was noted that it was damaged.
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Search Alerts/Recalls
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