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Model Number FA-55160-1030 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/14/2022 |
Event Type
malfunction
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Event Description
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Medtronic received information that marksman marker band was dislodged.The marksman was being advance over the guidewire and before entering the supraclinoid level, the physician did an angiogram "run".When the physician began to advance the catheter again, he realized that he couldn't see the tip of the catheter.He then noticed the catheter's markerband in a very distal 4th division of the anterior cerebral artery.He pulled out the catheter and used a different one to complete the procedure.The catheter tip was not shaped.The marker band remains in patient in the a4 location.No surgical or medical intervention is required.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per ifu.The patient wa being treated for an mechanical thrombectomy.Vessel tortuosity was normal.The access vessel was the internal carotid artery (ica) to the middle cerebral artery (mca).The access vessel diameter was 2mm.No patient symptoms or complications were reported. ancillary devices: 8f shuttle sheath, red 68 guide catheter, synchro ii solf guidewire.
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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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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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New information was received.The physician stated as he was advancing the catheter up the internal carotid, he couldn¿t see the catheter tip.He did a run for a roadmap for navigation and still couldn¿t see the tip of the catheter.After examining the imaging, he noticed it was distally lodged in a small vessel.He said there was no reason or difficulty to explain why the marker band separated.
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Search Alerts/Recalls
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