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Model Number H1-M |
Device Problems
Material Deformation (2976); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was attempting to use a hawkone directional atherectomy along with non-medtornic 6fr sheath and 0.014 guide wire during procedure to treat a none calcified plaque soft tissue in the left mid superfecial femoral artery (sfa) with 70% stenosis.The vessel diameter and lesion length are 6mm and 120mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.The nose cone split.Another device was used to complete the procedure.There was no patient injury reported.
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Manufacturer Narrative
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Additional information: the device did not pass through a previously deployed stent.No embolic protection was used.There was no damage noted to the device packaging.There was no difficulty removing the device from the hoop/tray.The device was introduced into the patient's vasculature.The issue occurred during cleaning.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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Manufacturer Narrative
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Product analysis: the hawkone device was loosely returned within a clear biohazard bag.Images were returned with the device also.No ancillary devices were received.The cutter driver (cd) was returned attached to the device.Visual inspection revealed a bulge in the housing.The bulge was located approx.1.9cm distal to the cutter window.The bulge was located on the same plane as the cutter window.The cutter was also distal to the bulge was advanced approx.Located approx.2.1cm distal to the cutter window.Microscopic inspection revealed tearing of the tecothane upon initial examination.The inner laser drilled coils were stretched, bent, and separated at the location of the bulge.Biological debris was noted at the location.No anomalies were observed with the guidewire lumen.During functional testing, the cd was activated, and the cutter was retracted into the cutter window.No anomalies were noted with the cutter.A 0.014¿ guidewire from the lab was then advanced through the device lumen.No anomalies were noted during advancement.No tearing of the lumen was observed.Image review: two photographic images were returned for review.One of the photographs contained the distal end of the housing assembly and the black duckbilled valve on the distal flushing tool.A bulge was noted midway along the housing.The second photograph contained a closer image of the bulge.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.
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Search Alerts/Recalls
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