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Catalog Number H1-LS |
Device Problems
Material Deformation (2976); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis the device was returned stuck on a 0.014¿ spider fx device.It was found that the proximal end of the housing was stretched, and that the guidewire lumen was detached and stuck on the spider fx wire 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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Event Description
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Physician attempted to use a hawkone ls atherectomy device during treatment of a 60mm calcified lesion in the patient¿s right proximal superficial femoral artery (sfa).Severe vessel tortuosity and severe vessel calcification were reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter reported as 7mm.There were abnormalities reported in relation to anatomy.Steep iliac bi-furcation and heavy calcium were reported.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported the device would not cross cto after pre-dilating to 3mm, moderate pressure was applied, minimal rotation, there was no wire wrap.Would not remove from the body without bringing the wire back.The device was safely removed with no patient harm.Once removed, upon inspection, the guidewire lumen was torn from the nosecone but the guidewire lumen had not fully detached from device.No patient injury reported.When the device was returned to the manufacturing facilty for evaluation, it was noted that the device was damaged.
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Search Alerts/Recalls
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