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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 10/13/2023 |
Event Type
malfunction
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Event Description
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A hawkone device was used for treatment of a fibrous plaque lesion in the mid right superficial femoral artery.The artery was 6mm in diameter with mild tortuosity and moderate calcification.A 6fr non medtronic sheath was used and a 0.14 non medtronic guidewire.The vessel was not pre-dilated.The ifu was followed.It was reported after one pass, turned off to pack and nosecone looked 3/4 full, turned on again for another pass, packed again and device was then only 1/4 full.Took device out of body to clean and looked at nosecone and plaque was coming out of side of nosecone, the plaque looked to be bulging out of side.The device had made enough lumen gain for a dcb to complete the procedure.There was no patient injury.
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Manufacturer Narrative
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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 device was returned with the distal flush tool (dft) positioned over the nosecone.The dft was retracted, and a visual inspection found a bulge on the distal end of the nosecone and biologics in the nosecone.The tecothane appears to be split.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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Search Alerts/Recalls
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