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Model Number H1-M |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Difficult to Advance (2920)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/11/2022 |
Event Type
Injury
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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 was attempting to use a hawkone directional atherectomy along with a non-medtronic 6fr sheath, 0.014" guidewire and 6mm spider embolic protection during procedure to treat a moderately calcified plaque lesion in the proximal superficial femoral artery with 30% stenosis.The vessel was little tortuous.The vessel was pre and post dilated.Ifu was followed.Tip detached/tip damage occurred with no resistance felt.The guidewire prolapsed and caused the tip damage.The tip broke, and plastic peaked away on the nosecone.It was reported that the procedure was completed by dissecting the hawkone and breaking device further to remove.Device was intact outside of the body, but coming apart.There was kink on the spider wire.The spider wire was cut, and the hawkone was taken apart at nosecone and removed from the body.No surgical intervention required for removal.It is unknown if there was any vessel damage noted.There was no perforation or dissection noted on final angiogram.No further injury reported.
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Manufacturer Narrative
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Product analysis: the device returned coiled inside its pouch in three biohazard bags.Lot number on pouch label: 0010730249.Device was decontaminated with cidex opa solution soak and tergazyme soak.A visual inspection showed that the tip detached from the housing, the guidewire lumen detached from the housing, and damage to the proximal end of the housing.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.
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Search Alerts/Recalls
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