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Catalog Number THP-S |
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 12/26/2023 |
Event Type
malfunction
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Event Description
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Physician was attempting to use a turbohawk plus-s 6f atherectomy device during treatment of a plaque lesion in the patient¿s distal superficial femoral artery (sfa).No vessel tortuosity and no vessel calcification are reported.Lesion exhibited 85% stenosis.Artery diameter reported as 5mm.There were no abnormalities reported in relation to anatomy.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.The device was removed from the patient after doing the atherectomy.The physician wanted to clean the device.Upon cleaning the device per ifu the device was re-introduced into the target lesion for a second pass atherectomy.Upon delivering the device back into the patient and to the target lesion, the operator noticed resistance in the thumb switch and removed the device for inspection.Upon inspection, the physician noticed the nose cone was perforated and decided to end the atherectomy portion of the procedure.The procedure was completed with balloon angioplasty.No patient injury reported.
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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 a bulge on the housing approximately 20mm from the cutter window and the cutter positioned approximately 22mm from the cutter window.The cutter cannot be retracted past the bulge.Housing wall and tecothane are intact.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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