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Model Number UNK-NV-MARATHON |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Event Description
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Medtronic received a report that 2 marathon catheters leaked during an animal study.One leak was confirmed and identified while it happened.The other was unconfirmed but believed to have leaked.Ancillary devices include onyx.
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Manufacturer Narrative
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The confirmed marathon leak was previously reported in manufacturer report # 2029214-2022-00555.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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Event Description
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Additional information received reported physician did not detect the leak.It wasn't until 3-months later when r & d performed a follow-up on the animal that we detected evidence of a leak.The theory is that onyx leaked from the microcatheter into the delivery catheter.The onyx formed a cast within the delivery catheter which was then pushed into the aorta during a saline flush of the delivery catheter.The cast then travelled down the descending aorta and logged in the internal femoral artery, where it was discovered 3-months later during a follow-up exam of the animal.The location of the leak was unknown.R & d suspects the leak occurred about 15-25 cm distal from the tip of the microcatheter.
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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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