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Catalog Number THP-M |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2023 |
Event Type
malfunction
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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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Event Description
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Physician was attempting to use a turbohawk plus 6f atherectomy device with a 6x45 non-medtronic sheath and a 6mm spider fx embolic protection device/guidewire during a procedure to treat an 80mm calcified lesion in the patient¿s mid left superficial femoral artery (sfa).Moderate vessel tortuosity and moderate vessel calcification are reported.Lesion exhibited 70% stenosis.Artery diameter reported as 6mm.There were no abnormalities reported in relation to anatomy.The device was inspected with no issues noted.Device was prepped per the ifu with no issues identified.A packing issue is reported.The cutter went through the cutter window, the cutter was outside on removal from the patient.The device was able to be safely removed from the patient with no vessel damage noted.No patient injury reported.The procedure was completed by angioplasty and a closure device.
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Manufacturer Narrative
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Image analysis: the customer returned one image.The image shows a turbohawk plus device with the cutter outside the housing/nosecone.Product analysis: the device was received with the distal end of driveshaft and cutter outside housing.A visual inspection found damage to the housing just distal to the cutter window.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.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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