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Model Number H1-LX |
Device Problems
Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
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 used a hawkone atherectomy device during treatment of a 40cm calcified and plaque cto (chronic total occlusion-100%) in the patient's proximal, mid, and distal superficial femoral artery (sfa).Slight vessel tortuosity and moderate calcification are reported.Artery diameter reported as 6mm.The device was inspected with no issues noted.The device was prepped as per ifu.It is reported during cleaning of the device not everything would come out.The thumb-switch would not go all the way forward.It was possible to turn off the thumbswitch.Cutter did not crash.It just felt like the nosecone was full and had to be cleaned.Did not have as much slack on the thumbswitch.Further inspection revealed more debris in nose cone.The cutter window and cleaning port were opened and the physician distally inserted back end of micro wire in cutter window to dislodge visible debris which looked like plastic from sheath or flush tool.In addition to the regular plaque debris, the plastic strip was also in the nosecone.The physician commented this is not the first time he has experienced this, it has happened in the past.Device was safely removed from patient.Position of cutter relative to nosecone during removal from patient unknown.No deformation noted in cutter.No detachment occurred.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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Search Alerts/Recalls
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